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    Clinical Trial Results:
    An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing a New 80 Milligram (2x40 mg) Pediatric Appropriate Formulation to an 80 Milligram Commercial Atorvastatin Calcium Tablet Formulation in Healthy Subjects

    Summary
    EudraCT number
    		 2012-000706-30
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Mar 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    A2581175
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00758004
    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 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, 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
    27 Jul 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether 80 milligram (mg) (2x40 mg) of the new formulation atorvastatin calcium chewable tablets were bioequivalent to one 80 mg commercial atorvastatin calcium tablet (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
    13 Oct 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
    United States: 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

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Total 76 subjects were enrolled in a single center of United States. Of these 76 subjects, only 75 subjects were treated. Study started from 13 October 2008 and completed on 06 March 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 40 mg (80 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 80 mg .

    Number of subjects in period 1
    		New Atorvastatin Then Commercial Atorvastatin Commercial Atorvastatin Then New Atorvastatin
    Started
    39
    37
    Completed
    38
    32
    Not completed
    1
    5
         Adverse event
    1
    2
         Unspecified
    -
    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
    38
    32
    Completed
    38
    32
    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
    		 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
    		 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 80 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 40 mg (80 mg) new atorvastatin calcium chewable tablets.

    Number of subjects in period 3
    		New Atorvastatin Then Commercial Atorvastatin Commercial Atorvastatin Then New Atorvastatin
    Started
    38
    32
    Completed
    38
    32

    Baseline characteristics

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    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)
    		 35.9 ± 9 -
    Gender categorical
    Units: Subjects
        Female
    		 17 17
        Male
    		 59 59

    End points

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    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
    		 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
    		 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 40 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 80 mg administered in either first or second intervention period.

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

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    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
    73
    75
    Units: nanogram*hour per milliliter (ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    128.2 ± 43
    121.3 ± 41
    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
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Percent geometric mean (GM) ratio
    Point estimate
    105.55
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 100.34
         upper limit
    		 111.03

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

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    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
    73
    75
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    131.9 ± 41
    124.5 ± 40
    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
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Percent GM ratio
    Point estimate
    105.73
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 100.69
         upper limit
    		 111.02

    Primary: Maximum Observed Plasma Concentration (Cmax) of Atorvastatin

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    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
    73
    75
    Units: nanogram per milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    29.23 ± 49
    28.94 ± 50
    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
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Percent GM ratio
    Point estimate
    101.37
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 92.39
         upper limit
    		 111.23

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

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    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
    73
    75
    Units: hour
        median (full range (min-max))
    0.5 (0.25 to 6.02)
    0.5 (0.5 to 6)
    No statistical analyses for this end point

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

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    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
    73
    75
    Units: hour
        arithmetic mean (standard deviation)
    6.059 ± 2.3267
    6.479 ± 2.0262
    No statistical analyses for this end point

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

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    End point title
    		 Area Under the Curve Last (AUClast) of Ortho- hydroxyatorvastatin (o- hydroxyatorvastatin) and 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. Here, 'n' signifies those subjects who were evaluable for this measure.
    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
    73
    75
    Units: ng*hr/mL
    geometric mean (geometric coefficient of variation)
        o- hydroxyatorvastatin (n=73, 75)
    158.9 ± 43
    153.2 ± 42
        p- hydroxyatorvastatin (n=72, 73)
    9.704 ± 78
    8.602 ± 77
    No statistical analyses for this end point

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

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Ortho- hydroxyatorvastatin (o-hydroxyatorvastatin) and 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. Here, 'n' signifies those subjects who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    0 to 72 hours post dose in Period 1 and Period 2
    End point values
    		 New Atorvastatin Commercial Atorvastatin
    Number of subjects analysed
    73
    75
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        o- hydroxyatorvastatin (n=73, 75)
    22.33 ± 61
    22.42 ± 49
        p- hydroxyatorvastatin (n=72, 73)
    0.883 ± 66
    0.833 ± 58
    No statistical analyses for this end point

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

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    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ortho hydroxyatorvastatin (o-hydroxyatorvastatin) and 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. Here, 'n' signifies those subjects who were evaluable for this measure.
    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
    73
    75
    Units: hour
    median (full range (min-max))
        o- hydroxyatorvastatin (n=73, 75)
    1.017 (0.5 to 6.02)
    1 (0.5 to 6)
        p- hydroxyatorvastatin (n=72, 73)
    9 (0.5 to 72)
    9 (0.5 to 12.1)
    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)

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    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 (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
    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
    73
    75
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    163.5 ± 43
    157.8 ± 41
    No statistical analyses for this end point

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

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    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
    73
    75
    Units: hour
        arithmetic mean (standard deviation)
    8.681 ± 3.2453
    9.101 ± 4.2237
    No statistical analyses for this end point

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

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    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 participant 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.
    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
    73
    75
    Units: subjects
        number (not applicable)
    19
    14
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 30 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 non serious 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 40 mg administered in either first or second intervention period.

    Reporting group title
    Commercial Atorvastatin
    Reporting group description
    		 A single commercial atorvastatin tablet of 80 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 / 73 (0.00%)
    0 / 75 (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
    19 / 73 (26.03%)
    14 / 75 (18.67%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    Transaminases increased
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 75 (1.33%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 73 (1.37%)
    2 / 75 (2.67%)
         occurrences all number
    2
    2
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 73 (1.37%)
    2 / 75 (2.67%)
         occurrences all number
    1
    2
    Pain
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    4 / 73 (5.48%)
    1 / 75 (1.33%)
         occurrences all number
    4
    1
    Dyspepsia
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 75 (1.33%)
         occurrences all number
    1
    1
    Epistaxis
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 73 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    2
    Sneezing
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 75 (1.33%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    3 / 73 (4.11%)
    3 / 75 (4.00%)
         occurrences all number
    3
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 75 (1.33%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 75 (1.33%)
         occurrences all number
    1
    1

    More information

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    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
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