Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing a Pediatric Appropriate Formulation to a 10 Milligram Commercial Atorvastatin Calcium Tablet Formulation in Healthy Subjects

    Summary
    EudraCT number
    		 2012-000728-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    01 Feb 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2016
    First version publication date
    29 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A2581174
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00777517
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800 7181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800 7181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000073-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jul 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether two 5 milligram (mg) tablets of a new atorvastatin calcium chewable tablet formulation were bioequivalent to one 10 mg commercial atorvastatin calcium tablet formulation (Lipitor).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Nov 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Singapore: 76
    Worldwide total number of subjects
    76
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    76
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Total 76 subjects were enrolled in a single center of Singapore. Study started from 12 November 2008 and completed on 01 February 2009.

    Period 1
    Period 1 title
    First Intervention Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 New Atorvastatin Then Commercial Atorvastatin
    Arm description
    		 Two chewable tablets of new atorvastatin were administered on Day 1 of first intervention period of 5 days. A washout period of at least 14 days was maintained between the two periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    New Atorvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received two 5 mg (10 mg) new atorvastatin calcium chewable tablets.

    Arm title
    		 Commercial Atorvastatin Then New Atorvastatin
    Arm description
    		 A single tablet of commercial atorvastatin was administered on Day 1 of first intervention period of 5 days. A washout period of at least 14 days was maintained between the two periods.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Commercial Atorvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single commercial atorvastatin calcium tablet of 10 mg .

    Number of subjects in period 1
    		New Atorvastatin Then Commercial Atorvastatin Commercial Atorvastatin Then New Atorvastatin
    Started
    39
    37
    Completed
    39
    33
    Not completed
    0
    4
         Other
    -
    1
         No longer willing to participate
    -
    3
    Period 2
    Period 2 title
    Washout Period (At Least 14 Days)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 New Atorvastatin Then Commercial Atorvastatin
    Arm description
    		 Two new atorvastatin calcium chewable tablets administered on Day 1 of each of the two treatment periods of 5 days. A washout period of at least 14 days was maintained between the two periods.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Commercial Atorvastatin Then New Atorvastatin
    Arm description
    		 Single commercial atorvastatin calcium tablet administered on Day 1 of each of the two treatment periods of 5 days. A washout period of at least 14 days was maintained between the two periods.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		New Atorvastatin Then Commercial Atorvastatin Commercial Atorvastatin Then New Atorvastatin
    Started
    33
    39
    Completed
    33
    39
    Period 3
    Period 3 title
    Second Intervention Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 New Atorvastatin Then Commercial Atorvastatin
    Arm description
    		 Subjects who received new atorvastatin in the first intervention period, were administered with a single tablet of commercial atorvastatin on Day 1 of second intervention period of 5 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Commercial Atorvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single commercial atorvastatin calcium tablet of 10 mg .

    Arm title
    		 Commercial Atorvastatin Then New Atorvastatin
    Arm description
    		 Subjects who received commercial atorvastatin in the first intervention period, were administered with two chewable tablets of new atorvastatin on Day 1 of second intervention period of 5 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    New Atorvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received two 5 mg new atorvastatin calcium chewable tablets.

    Number of subjects in period 3
    		New Atorvastatin Then Commercial Atorvastatin Commercial Atorvastatin Then New Atorvastatin
    Started
    39
    33
    Completed
    39
    33

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    First Intervention Period
    Reporting group description
    		 -

    Reporting group values
    		 First Intervention Period Total
    Number of subjects
    		 76 76
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.7 ± 6.4 -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 70 70

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    New Atorvastatin Then Commercial Atorvastatin
    Reporting group description
    		 Two chewable tablets of new atorvastatin were administered on Day 1 of first intervention period of 5 days. A washout period of at least 14 days was maintained between the two periods.

    Reporting group title
    Commercial Atorvastatin Then New Atorvastatin
    Reporting group description
    		 A single tablet of commercial atorvastatin was administered on Day 1 of first intervention period of 5 days. A washout period of at least 14 days was maintained between the two periods.
    Reporting group title
    New Atorvastatin Then Commercial Atorvastatin
    Reporting group description
    		 Two new atorvastatin calcium chewable tablets administered on Day 1 of each of the two treatment periods of 5 days. A washout period of at least 14 days was maintained between the two periods.

    Reporting group title
    Commercial Atorvastatin Then New Atorvastatin
    Reporting group description
    		 Single commercial atorvastatin calcium tablet administered on Day 1 of each of the two treatment periods of 5 days. A washout period of at least 14 days was maintained between the two periods.
    Reporting group title
    New Atorvastatin Then Commercial Atorvastatin
    Reporting group description
    		 Subjects who received new atorvastatin in the first intervention period, were administered with a single tablet of commercial atorvastatin on Day 1 of second intervention period of 5 days.

    Reporting group title
    Commercial Atorvastatin Then New Atorvastatin
    Reporting group description
    		 Subjects who received commercial atorvastatin in the first intervention period, were administered with two chewable tablets of new atorvastatin on Day 1 of second intervention period of 5 days.

    Subject analysis set title
    New Atorvastatin
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Two new atorvastatin calcium chewable tablets of 5 mg administered in either first or second intervention period.

    Subject analysis set title
    Commercial Atorvastatin
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    A single commercial atorvastatin tablet of 10 mg administered in either first or second intervention period.

    Primary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Atorvastatin

    		 Close Top of page
    End point title
    		 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Atorvastatin
    End point description
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Primary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    75
    76
    Units: nanogram*hour per milliliter (ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    21.51 ± 43
    19.8 ± 43
    Statistical analysis title
    		 AUClast
    Statistical analysis description
    Natural log transformed AUClast of atorvastatin was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and subject within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (New/Commercial) and 90% CIs for the ratios.
    Comparison groups
    New Atorvastatin v Commercial Atorvastatin
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Percent geometric mean (GM) ratio
    Point estimate
    103.48
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 99.34
         upper limit
    		 107.79

    Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Atorvastatin

    		 Close Top of page
    End point title
    		 Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Atorvastatin
    End point description
    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Primary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    75
    76
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    22.82 ± 40
    22.14 ± 41
    Statistical analysis title
    		 Statistical analysis for AUCinf
    Statistical analysis description
    Natural log transformed AUCinf of atorvastatin was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and subject within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (New/Commercial) and 90% CIs for the ratios.
    Comparison groups
    New Atorvastatin v Commercial Atorvastatin
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Percent GM ratio
    Point estimate
    102.91
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 99.02
         upper limit
    		 106.96

    Primary: Maximum Observed Plasma Concentration (Cmax) of Atorvastatin

    		 Close Top of page
    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Atorvastatin
    End point description
    The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Primary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    75
    76
    Units: nanogram per milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    3.799 ± 52
    3.508 ± 42
    Statistical analysis title
    		 Statistical analysis for Cmax
    Statistical analysis description
    Natural log transformed Cmax of atorvastatin was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and subject within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (New/Commercial) and 90% CIs for the ratios.
    Comparison groups
    New Atorvastatin v Commercial Atorvastatin
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Percent GM ratio
    Point estimate
    108.13
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 98.75
         upper limit
    		 118.4

    Secondary: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin

    		 Close Top of page
    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin
    End point description
    The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Secondary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    75
    76
    Units: hour
        median (full range (min-max))
    0.5 (0.25 to 1.5)
    0.5 (0.4 to 4)
    No statistical analyses for this end point

    Secondary: Plasma Decay Half-Life (t1/2) of Atorvastatin

    		 Close Top of page
    End point title
    		 Plasma Decay Half-Life (t1/2) of Atorvastatin
    End point description
    Plasma decay half-life was the time measured for the plasma concentration to decreased by one half of its initial concentration. The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Secondary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    75
    76
    Units: hour
        arithmetic mean (standard deviation)
    10.21 ± 2.93
    10.34 ± 2.998
    No statistical analyses for this end point

    Secondary: Area Under the Curve Last (AUClast) of Ortho-hydroxyatorvastatin (o-hydroxyatorvastatin)

    		 Close Top of page
    End point title
    		 Area Under the Curve Last (AUClast) of Ortho-hydroxyatorvastatin (o-hydroxyatorvastatin)
    End point description
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Secondary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    75
    76
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    21.84 ± 41
    21.62 ± 42
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration Time Profile From Zero Extrapolated to Infinite Time (AUC inf) of Ortho-hydroxyatorvastatin (o-hydroxyatorvastatin)

    		 Close Top of page
    End point title
    		 Area Under the Plasma Concentration Time Profile From Zero Extrapolated to Infinite Time (AUC inf) of Ortho-hydroxyatorvastatin (o-hydroxyatorvastatin)
    End point description
    AUC (0 ­ ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre­dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 ­- t) plus AUC (t ­ - ∞). The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Secondary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    75
    76
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    24.45 ± 37
    24.4 ± 37
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of Ortho-hydroxyatorvastatin (o-hydroxyatorvastatin)

    		 Close Top of page
    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Ortho-hydroxyatorvastatin (o-hydroxyatorvastatin)
    End point description
    The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Secondary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    75
    76
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    1.482 ± 52
    1.519 ± 53
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ortho hydroxyatorvastatin (o-hydroxyatorvastatin)

    		 Close Top of page
    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) of ortho hydroxyatorvastatin (o-hydroxyatorvastatin)
    End point description
    The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Secondary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    75
    76
    Units: hour
        median (full range (min-max))
    4 (0.5 to 9.02)
    3.517 (0.48 to 9)
    No statistical analyses for this end point

    Secondary: Plasma Decay Half-Life (t1/2) of Ortho-hydroxyatorvastatin (o-hydroxyatorvastatin)

    		 Close Top of page
    End point title
    		 Plasma Decay Half-Life (t1/2) of Ortho-hydroxyatorvastatin (o-hydroxyatorvastatin)
    End point description
    Plasma decay half-life was the time measured for the plasma concentration to decreased by one half of its initial concentration. The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Secondary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    75
    75 [1]
    Units: hour
        arithmetic mean (standard deviation)
    10.82 ± 2.328
    11.03 ± 3.263
    Notes
    [1] - Subjects evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Area Under the Curve Last (AUClast) of Para-hydroxyatorvastatin (p-hydroxyatorvastatin)

    		 Close Top of page
    End point title
    		 Area Under the Curve Last (AUClast) of Para-hydroxyatorvastatin (p-hydroxyatorvastatin)
    End point description
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Secondary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    0 [2]
    41 [3]
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    ±
    1.018 ± 2.474
    Notes
    [2] - Data was not estimable as plasma concentrations were below limit of quantitation for all subjects. 
    [3] - Subjects evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of Para- hydroxyatorvastatin (p-hydroxyatorvastatin)

    		 Close Top of page
    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Para- hydroxyatorvastatin (p-hydroxyatorvastatin)
    End point description
    The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Secondary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    0 [4]
    41 [5]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    ±
    0.149 ± 0.085
    Notes
    [4] - Data was not estimable as plasma concentrations were below limit of quantitation for all subjects.
    [5] - Subjects evaluable for this end point.  
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Para- hydroxyatorvastatin (p-hydroxyatorvastatin)

    		 Close Top of page
    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) of Para- hydroxyatorvastatin (p-hydroxyatorvastatin)
    End point description
    The PK concentration population was defined as all subjects randomized and treated who have at least 1 concentration in at least 1 treatment period.
    End point type
    Secondary
    End point timeframe
    Day 1 pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    0 [6]
    41 [7]
    Units: hour
        median (full range (min-max))
    ( to )
    12 (0.48 to 24)
    Notes
    [6] - Data was not estimable as plasma concentrations were below limit of quantitation for all subjects. 
    [7] - Subjects evaluable for this end point.
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

    		 Close Top of page
    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a subject who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Safety analysis set was defined as all subjects who received at least 1 dose of study medication.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to 28 days after last dose of study drug
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    75
    76
    Units: subjects
        number (not applicable)
    5
    4
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 28 days after the last administration of the study drug
    Adverse event reporting additional description
    The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    New Atorvastatin
    Reporting group description
    		 Two new atorvastatin calcium chewable tablets of 5 mg administered in either first or second intervention period.

    Reporting group title
    Commercial Atorvastatin
    Reporting group description
    		 A single commercial atorvastatin tablet of 10 mg administered in either first or second intervention period.

    Serious adverse events
    		 New Atorvastatin Commercial Atorvastatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 76 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 New Atorvastatin Commercial Atorvastatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 75 (6.67%)
    4 / 76 (5.26%)
    Vascular disorders
    Bloody discharge
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    Paraesthesia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Hordeolum
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 76 (1.32%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 00:12:52 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA