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    Clinical Trial Results:
    Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson's Disease experiencing motor fluctuations

    Summary
    EudraCT number
    		 2017-000262-30
    Trial protocol
    		 IT  
    Global end of trial date
    30 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2021
    First version publication date
    28 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EXN-32-CD-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 NA: NA
    Sponsors
    Sponsor organisation name
    Dr. Reddy's Laboratories Ltd.
    Sponsor organisation address
    8-2-337 Road no. 3, Banjara Hills , Hyderabad , India, 500034
    Public contact
    Clinical Operation, TFS Trial Form Support, +39 068076072, paola.tiradritti@tfscro.com
    Scientific contact
    Clinical Operation, TFS Trial Form Support, +39 068076072, paola.tiradritti@tfscro.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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
    22 May 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate following pharmacodynamic properties of EXN-32 and EXN-44, and compare them with SINEMET®. Time to resolution of "OFF" period following administration of EXN-32 and EXN-44. Duration of "ON" period following dosing. Proportion of patients evaluated to be in the "ON" state at 05, 15, 30, 60, 90, and 120 minutes after administration of EXN-32, and EXN-44. UPDRS Part III motor score at 10, 20, 30, 60, 90, and 120 minutes after each dose of study medication in each period. To estimate the pharmacokinetic profiles of levodopa and carbidopa. Maximum plasma concentration (Cmax). Time to reach maximum plasma concentration (Tmax). Area under the concentration-time curve from time zero to last measured concentration (AUC0-t). The secondary objective of the trial is to evaluate PK/PD relationship, safety and tolerability of EXN-32 and EXN-44
    Protection of trial subjects
    All subjects will have a full safety evaluation at the end of study visit. For all the subjects, an end of treatment visit was scheduled 7 days after the last dose of study medication. During this visit, clinical laboratory test, urine analysis, urine pregnancy test (for women of child bearing potential only), vital signs, 12-lead ECG, and adverse events were monitored for all the subjects.
    Background therapy
    		 Parkinson’s disease is a progressive disorder in which the patient’s response to pharmacotherapy decreases overtime, resulting in various motor complications such as inadequate dopaminergic tone ("OFF" time and dose failures) and excess dopaminergic tone (dyskinesia). The prevalence of motor fluctuations, or movement problems, is reported to be as high as 60 - 90% in patients after 5 - 10 years of treatment. There are several non-levodopa therapies like dopamine agonists, MAO-B inhibitors and catechol-O-methyltransferase (COMT) inhibitors available in the market for treatment of Parkinson’s disease, but levodopa is the most effective oral pharmacotherapy, and is typically administered in combination with a DDCI inhibitor such as carbidopa.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Apr 2017
    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
    Italy: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    16
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients (male or female, aged 40 years or higher) receiving stable regimen of levodopa for at least one month before screening with or without concomitant therapy with dopamine agonists, COMT inhibitors, MAO-B inhibitors, or amantadine and with at least 3 “OFF” periods per day based on their medical records were selected.

    Pre-assignment
    Screening details
    		 25 patients were screened based on IC/EC and 18 patients were selected and randomized. Of the 18 patients, 17 patients completed the study. There were 3 treatment periods; in each period, the patients were treated with 3 doses of either A (EXN-32), B (EXN-44) or C (SINEMET) at 3 hours interval. The treatment sequences were ABC, BCA and CAB.

    Period 1
    Period 1 title
    Treatment Period I
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Data analyst [1]
    Blinding implementation details
    The evaluator for PD assessments (“ON” and “OFF” assessments) and the laboratory staff in charge of bioanalysis of plasma samples (PK concentration measurements) were blinded to the randomization code.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment A
    Arm description
    		 1st dose EXN-32, 2nd dose EXN-32, and 3rd dose EXN-32. Each administration will be 5 mL of EXN-32 leading to a dose of 15 / 150 mg of carbidopa / levodopa. Dosing interval is 3 hours after administration of each dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EXN-32 (Carbidopa and Levodopa) Oral Suspension
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    3 doses to be administered at dosing intervals of 3 hours after each dose

    Arm title
    		 Treatment B
    Arm description
    		 1st dose EXN-44, 2nd dose SINEMET®, and 3rd dose EXN-44. Each administration of EXN-44 will be 6.5 mL leading to a dose of 195 mg of levodopa. Dosing interval is of 3 hours after administration of each dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EXN-44 ( Levodopa) Oral Suspension
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    To be administered at intervals of 3 hours

    Arm title
    		 Treatment C
    Arm description
    		 1st dose SINEMET®, 2nd dose SINEMET®, and 3rd dose SINEMET®. Dosing interval is 3 hours after administration of each dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SINEMET
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 doses to be administered at dosing interval of 3 hours after each dose.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The data analyst were blinded in the clinical trial.
    Number of subjects in period 1
    		Treatment A Treatment B Treatment C
    Started
    8
    5
    5
    Completed
    8
    5
    5
    Period 2
    Period 2 title
    Treatment Period II
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Data analyst [2]
    Blinding implementation details
    The evaluator for PD assessments (“ON” and “OFF” assessments) and the laboratory staff in charge of bioanalysis of plasma samples (PK concentration measurements) were blinded to the randomization code.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment B
    Arm description
    		 1st dose EXN-44, 2nd dose SINEMET®, and 3rd dose EXN-44. Each administration of EXN-44 will be 6.5 mL leading to a dose of 195 mg of levodopa. Dosing interval is 3 hours after administration of each dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EXN-44 ( Levodopa) Oral Suspension
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    To be administered at intervals of 3 hours

    Arm title
    		 Treatment C
    Arm description
    		 1st dose SINEMET®, 2nd dose SINEMET®, and 3rd dose SINEMET®. Dosing interval is 3 hours after administration of each dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SINEMET
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 doses to be administered at dosing interval of 3 hours after each dose.

    Arm title
    		 Treatment A
    Arm description
    		 3 doses EXN-32, each administration will be 5 mL of EXN-32 leading to a dose of 15 / 150 mg of carbidopa / levodopa. Dosing interval is of 3 hours after administration of each dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    EXN-32 (Carbidopa and Levodopa) Oral Suspension
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    3 doses to be administered at dosing intervals of 3 hours after each dose

    Notes
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The data analyst were blinded in the clinical trial.
    Number of subjects in period 2 [3]
    		Treatment B Treatment C Treatment A
    Started
    8
    5
    4
    Completed
    8
    5
    4
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The arms are mutually exclusive arms
    Period 3
    Period 3 title
    Treatment Period III
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Data analyst [4]
    Blinding implementation details
    The evaluator for PD assessments (“ON” and “OFF” assessments) and the laboratory staff in charge of bioanalysis of plasma samples (PK concentration measurements) were blinded to the randomization code.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment C
    Arm description
    		 1st dose SINEMET®, 2nd dose SINEMET®, and 3rd dose SINEMET. Dosing interval is 3 hours after administration of each dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SINEMET
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 doses to be administered at dosing interval of 3 hours after each dose.

    Arm title
    		 Treatment A
    Arm description
    		 3 doses of EXN-32, each administration will be 5 mL of EXN-32 leading to a dose of 15 / 150 mg of carbidopa / levodopa. Dosing interval is of 3 hours after administration of each dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EXN-32 (Carbidopa and Levodopa) Oral Suspension
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    3 doses to be administered at dosing intervals of 3 hours after each dose

    Arm title
    		 Treatment B
    Arm description
    		 1st dose EXN-44, 2nd dose SINEMET®, and 3rd dose EXN-44. Each administration of EXN-44 will be 6.5 mL leading to a dose of 195 mg of levodopa. Dosing interval is of 3 hours after administration of each dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EXN-44 ( Levodopa) Oral Suspension
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    To be administered at intervals of 3 hours

    Notes
    [4] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The data analyst were blinded in the clinical trial.
    Number of subjects in period 3
    		Treatment C Treatment A Treatment B
    Started
    8
    5
    4
    Completed
    8
    5
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period I
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Period I Total
    Number of subjects
    		 18 18
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 16 16
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.61 ( 10.32 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Treatment A
    Reporting group description
    		 1st dose EXN-32, 2nd dose EXN-32, and 3rd dose EXN-32. Each administration will be 5 mL of EXN-32 leading to a dose of 15 / 150 mg of carbidopa / levodopa. Dosing interval is 3 hours after administration of each dose.

    Reporting group title
    Treatment B
    Reporting group description
    		 1st dose EXN-44, 2nd dose SINEMET®, and 3rd dose EXN-44. Each administration of EXN-44 will be 6.5 mL leading to a dose of 195 mg of levodopa. Dosing interval is of 3 hours after administration of each dose.

    Reporting group title
    Treatment C
    Reporting group description
    		 1st dose SINEMET®, 2nd dose SINEMET®, and 3rd dose SINEMET®. Dosing interval is 3 hours after administration of each dose.
    Reporting group title
    Treatment B
    Reporting group description
    		 1st dose EXN-44, 2nd dose SINEMET®, and 3rd dose EXN-44. Each administration of EXN-44 will be 6.5 mL leading to a dose of 195 mg of levodopa. Dosing interval is 3 hours after administration of each dose.

    Reporting group title
    Treatment C
    Reporting group description
    		 1st dose SINEMET®, 2nd dose SINEMET®, and 3rd dose SINEMET®. Dosing interval is 3 hours after administration of each dose.

    Reporting group title
    Treatment A
    Reporting group description
    		 3 doses EXN-32, each administration will be 5 mL of EXN-32 leading to a dose of 15 / 150 mg of carbidopa / levodopa. Dosing interval is of 3 hours after administration of each dose
    Reporting group title
    Treatment C
    Reporting group description
    		 1st dose SINEMET®, 2nd dose SINEMET®, and 3rd dose SINEMET. Dosing interval is 3 hours after administration of each dose.

    Reporting group title
    Treatment A
    Reporting group description
    		 3 doses of EXN-32, each administration will be 5 mL of EXN-32 leading to a dose of 15 / 150 mg of carbidopa / levodopa. Dosing interval is of 3 hours after administration of each dose.

    Reporting group title
    Treatment B
    Reporting group description
    		 1st dose EXN-44, 2nd dose SINEMET®, and 3rd dose EXN-44. Each administration of EXN-44 will be 6.5 mL leading to a dose of 195 mg of levodopa. Dosing interval is of 3 hours after administration of each dose.

    Subject analysis set title
    Treatment A, EXN-32 (For Carbidopa)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The PK parameters reported here is after the third dose EXN-32

    Subject analysis set title
    Treatment B, EXN-44 (For Carbidopa)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The PK parameters reported here is after the second dose, treatment being- SINEMET

    Subject analysis set title
    Treatment C, SINEMET (For Carbidopa)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The PK parameters reported here is after the third dose of SINEMET

    Subject analysis set title
    Treatment A, EXN-32 (For Levodopa)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The PK parameters reported here is after the third dose of EXN-32

    Subject analysis set title
    Treatment B, EXN-44 (For Levodopa)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The PK parameters reported here is at the third dose, treatment being EXN-44

    Subject analysis set title
    Treatment C, SINEMET (For Levodopa)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The PK parameters reported here is after the third dose of SINEMET

    Primary: Time to resolution of "OFF" period following dosing

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    End point title
    		 Time to resolution of "OFF" period following dosing [1]
    End point description
    End point type
    Primary
    End point timeframe
    Assessed at pre-dose, and at 05, 15, 30, 60, 90, and 120 minutes following each dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis set used was modified intent to treat population.
    End point values
    		 Treatment A Treatment B Treatment C Treatment B Treatment C Treatment A Treatment C Treatment A Treatment B
    Number of subjects analysed
    8
    5
    5
    8
    5
    4
    8
    5
    4
    Units: minutes
        arithmetic mean (standard deviation)
    30.83 ( 16.69 )
    39.00 ( 24.41 )
    32.67 ( 14.22 )
    44.94 ( 26.28 )
    69.33 ( 34.79 )
    14.58 ( 7.98 )
    62.29 ( 38.46 )
    33.00 ( 22.09 )
    33.75 ( 34.67 )
    No statistical analyses for this end point

    Primary: Duration of "ON" periods irrespective of Dyskinesia

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    End point title
    		 Duration of "ON" periods irrespective of Dyskinesia [2]
    End point description
    End point type
    Primary
    End point timeframe
    Assessed at pre-dose, and at 05, 15, 30, 60, 90, and 120 minutes following each dose
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis set used was modified intent to treat population.
    End point values
    		 Treatment A Treatment B Treatment C Treatment B Treatment C Treatment A Treatment C Treatment A Treatment B
    Number of subjects analysed
    8
    5
    5
    8
    5
    4
    8
    5
    4
    Units: Minutes
        arithmetic mean (standard deviation)
    80.42 ( 22.64 )
    76.00 ( 24.41 )
    80.33 ( 16.85 )
    68.13 ( 31.02 )
    42.67 ( 37.05 )
    100.42 ( 7.98 )
    47.71 ( 32.89 )
    80.00 ( 25.85 )
    81.25 ( 34.67 )
    No statistical analyses for this end point

    Primary: Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor score

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    End point title
    		 Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor score [3]
    End point description
    End point type
    Primary
    End point timeframe
    Assessed at 10, 20, 30, 60, 90 and 120 minutes after each dose medication in each period. The results provided is assessed 120 minutes after dose administration in each period.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis set used was modified intent to treat population.
    End point values
    		 Treatment A Treatment B Treatment C Treatment B Treatment C Treatment A Treatment C Treatment A Treatment B
    Number of subjects analysed
    8
    5
    5
    8
    5
    4
    8
    5
    4
    Units: change from baseline
        arithmetic mean (standard deviation)
    -18.44 ( 10.01 )
    -15.70 ( 14.32 )
    -15.90 ( 12.26 )
    -14.13 ( 11.02 )
    -8.80 ( 3.81 )
    -14.58 ( 1.64 )
    -9.71 ( 6.58 )
    -15.80 ( 4.27 )
    -20.25 ( 5.44 )
    No statistical analyses for this end point

    Primary: Cmax (Carbidopa)

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    End point title
    		 Cmax (Carbidopa) [4]
    End point description
    End point type
    Primary
    End point timeframe
    The blood samples were collected at pre-dose and at 5, 15, 30, 60, 90 and 120 minutes after each dose during each treatment period
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis set used was modified intent to treat population. ANOVA with 5% level of significance was employed.
    End point values
    		 Treatment A, EXN-32 (For Carbidopa) Treatment B, EXN-44 (For Carbidopa) Treatment C, SINEMET (For Carbidopa)
    Number of subjects analysed
    16
    16
    13
    Units: nanogram/milliliter
        arithmetic mean (standard deviation)
    41.472 ( 26.06 )
    20.350 ( 10.46 )
    34.517 ( 15.87 )
    No statistical analyses for this end point

    Primary: Tmax (Carbidopa)

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    End point title
    		 Tmax (Carbidopa) [5]
    End point description
    End point type
    Primary
    End point timeframe
    The blood samples were collected at pre-dose and at 5, 15, 30, 60, 90 and 120 minutes after each dose during each treatment period
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis set used was modified intent to treat population. ANOVA with 5% level of significance was employed.
    End point values
    		 Treatment A, EXN-32 (For Carbidopa) Treatment B, EXN-44 (For Carbidopa) Treatment C, SINEMET (For Carbidopa)
    Number of subjects analysed
    16
    16
    13
    Units: minutes
        arithmetic mean (full range (min-max))
    62.50 (0.00 to 95.00)
    105.00 (60.00 to 135.00)
    60.00 (0.00 to 130.00)
    No statistical analyses for this end point

    Primary: Area Under the Curve (AUC(0-t))- Carbidopa

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    End point title
    		 Area Under the Curve (AUC(0-t))- Carbidopa [6]
    End point description
    End point type
    Primary
    End point timeframe
    The blood samples were collected at pre-dose and at 5, 15, 30, 60, 90 and 120 minutes after each dose during each treatment period
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis set used was modified intent to treat population. ANOVA with 5% level of significance was employed.
    End point values
    		 Treatment A, EXN-32 (For Carbidopa) Treatment B, EXN-44 (For Carbidopa) Treatment C, SINEMET (For Carbidopa)
    Number of subjects analysed
    16
    16
    13
    Units: nanogram- minute/ milliliter
        arithmetic mean (standard deviation)
    3642.7 ( 2641.46 )
    1567.6 ( 981.80 )
    3370.2 ( 1578.30 )
    No statistical analyses for this end point

    Primary: Cmax (Levodopa)

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    End point title
    		 Cmax (Levodopa) [7]
    End point description
    End point type
    Primary
    End point timeframe
    The blood samples were collected at pre-dose and at 5, 15, 30, 60, 90 and 120 minutes after each dose during each treatment period
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis set used was modified intent to treat population. ANOVA with 5% level of significance was employed.
    End point values
    		 Treatment A, EXN-32 (For Levodopa) Treatment B, EXN-44 (For Levodopa) Treatment C, SINEMET (For Levodopa)
    Number of subjects analysed
    16
    16
    13
    Units: nanogram/ milliliter
        arithmetic mean (standard deviation)
    1456.275 ( 615.53 )
    1487.935 ( 774.63 )
    1022.843 ( 515.64 )
    No statistical analyses for this end point

    Primary: Tmax (Levodopa)

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    End point title
    		 Tmax (Levodopa) [8]
    End point description
    End point type
    Primary
    End point timeframe
    The blood samples were collected at pre-dose and at 5, 15, 30, 60, 90 and 120 minutes after each dose during each treatment period
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis set used was modified intent to treat population. ANOVA with 5% level of significance was employed.
    End point values
    		 Treatment A, EXN-32 (For Levodopa) Treatment B, EXN-44 (For Levodopa) Treatment C, SINEMET (For Levodopa)
    Number of subjects analysed
    16
    16
    13
    Units: minutes
        arithmetic mean (full range (min-max))
    30.00 (15.00 to 95.00)
    30.00 (15.00 to 120.00)
    60.00 (0.00 to 120.00)
    No statistical analyses for this end point

    Primary: Area Under the Curve (AUC(0-t))- Levodopa

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    End point title
    		 Area Under the Curve (AUC(0-t))- Levodopa [9]
    End point description
    End point type
    Primary
    End point timeframe
    The blood samples were collected at pre-dose and at 5, 15, 30, 60, 90 and 120 minutes after each dose during each treatment period
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis set used was modified intent to treat population. ANOVA with 5% level of significance was employed.
    End point values
    		 Treatment A, EXN-32 (For Levodopa) Treatment B, EXN-44 (For Levodopa) Treatment C, SINEMET (For Levodopa)
    Number of subjects analysed
    16
    16
    13
    Units: nanogram minute/ milliliter
        arithmetic mean (standard deviation)
    111841.5 ( 50923.61 )
    107661.9 ( 57305.41 )
    78365.4 ( 36179.78 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No serious adverse events were observed

    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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