Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC)

Sponsor
Zambon SpA (Industry)
Overall Status
Completed
CT.gov ID
NCT02265224
Collaborator
(none)
48
2

Study Details

Study Description

Brief Summary

Study primary Objective:
  • To evaluate the bioequivalent rate (Cmax) and extent (AUC0-t) of absorption of N-acetyl-cysteine 600 mg uncoated tablets vs. N-acetyl-cysteine 600 mg film-coated tablets (NAC) in healthy male and female volunteers.
Study secondary objectives:
  • To describe the pharmacokinetic (PK) profile of NAC in plasma after single dose administration of NAC 600 mg uncoated tablets vs. NAC 600 mg film-coated tablets;

  • to collect safety and tolerability data after single dose administration of NAC 600 mg uncoated tablets vs. NAC 600 mg film-coated tablets.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This is single centre, single dose, open, randomised, cross-over, two-stage bioequivalence study to compare two different oral formulations of NAC.

The study has been conducted in healthy volunteers of both genders, in one single dose of both formulations.

The initial 48 subjects were sufficient to satisfy the study objectives on the basis of the ad interim preliminary bioequivalence test. The study was then considered as concluded and the second stage did not take place.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparative Bioavailability Study of N-acetyl-cysteine (NAC) 600 mg Uncoated Tablets vs. NAC 600 mg Film-coated Tablets in Healthy Male and Female Volunteers
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test - Reference

N-acetylcysteine (NAC) 600 mg uncoated tablet (single dose) followed by NAC 600 mg film-coated tablet (single dose)

Drug: N-acetylcysteine
The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
Other Names:
  • Fluimucil uncoated tablets
  • Active Comparator: Reference - Test

    N-acetylcysteine (NAC) 600 mg film-coated tablet (single dose) followed by NAC 600 mg uncoated tablet (single dose)

    Drug: N-acetylcysteine
    The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
    Other Names:
  • Fluimucil uncoated tablets
  • Outcome Measures

    Primary Outcome Measures

    1. Cmax of NAC After Single Dose Administration of Test and Reference [0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)]

      Cmax is the maximum concentration level of the drug reached in plasma.

    2. AUC0-t of NAC After Single Dose Administration of Test and Reference [0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)]

      AUC0-t is the Area under the concentration-time curve from time zero to time t, calculated with the linear trapezoidal summation from time 0 to the last measurable data point.

    Secondary Outcome Measures

    1. AUC0-∞ of NAC After Single Dose Administration of Test and Reference [0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)]

      AUC0-∞ is the area under the concentration-time curve extrapolated to infinity, calculated, if feasible, as AUC0-t + Ct/λz, where Ct is the last measurable drug concentration.

    2. Tmax of NAC After Single Dose Administration of Test and Reference [0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)]

      time to achieve the maximum concentration level of the drug in plasma.

    3. t1/2 of NAC After Single Dose Administration of Test and Reference [0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)]

      Half-life (t1/2) is the time to halve the plasma concentration level of the drug.

    4. Lambda Zeta of NAC After Single Dose Administration of Test and Reference [0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)]

      Lambda zeta is the terminal elimination rate constant. Individual estimate of the terminal elimination rate constant can be calculated using log-linear regression of the terminal portions of the plasma concentration-versus-time curves.

    5. Frel of NAC After Single Dose Administration of Test and Reference [0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)]

      Frel is the relative bioavailability, calculated as ratio AUC0-t (test)/ AUC0-t (reference)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Informed consent: signed written informed consent before inclusion in the study

    2. Sex and age: males and females,18-55 years old, inclusive

    3. Body Mass Index (BMI): 18.5-30 kg/m2, inclusive

    4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 50-90 bpm, measured after 5 min of rest in the sitting position

    5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study

    6. Contraception and fertility (females only): females of child-bearing potential and with an active sexual life must be using at least one of the following reliable methods of contraception:

    • Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit

    • A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit

    • A male sexual partner who agrees to use a male condom with spermicide

    • A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted.

    For all female subjects, pregnancy test result must be negative at screening (serum β-HCG test) and day -1 (urine test).

    Exclusion Criteria:
    1. Electrocardiogram (ECG 12-leads, supine position): clinically significant abnormalities

    2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study

    3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness

    4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study

    5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study

    6. Medications: medications, including over the counter (OTC) medications and herbal remedies for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed

    7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study

    8. Blood donation: blood donations for 3 months before this study

    9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2010], caffeine (>5 cups coffee/tea/day) or tobacco abuse (≥6 cigarettes/day)

    10. Drug test: positive result at the drug test at screening or day-1

    11. Alcohol test: positive alcohol breath test at day -1

    12. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians

    13. Pregnancy (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zambon SpA

    Investigators

    • Principal Investigator: Milko Radicioni, MD, Cross Research SA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zambon SpA
    ClinicalTrials.gov Identifier:
    NCT02265224
    Other Study ID Numbers:
    • Z7169J02
    • CRO-PK-14-286
    First Posted:
    Oct 15, 2014
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zambon SpA
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details 48 healthy subjects were included in the study, as planned, and received test and reference treatment according to the cross-over design.
    Pre-assignment Detail Subjects were assigned to a sequence of treatments (TR or RT) according to the randomisation list. Randomisation number was given to the subjects on study day -1, Period 1, and was used to assign the treatment sequence according to the randomisation list. The randomisation list was computer-generated by the Contract Research Organisation (CRO) Biometry Unit, using the PLAN procedure of SAS® version 9.3 (TS1M1) (24). The randomisation list was supplied to the Phase I Unit before study start.
    Arm/Group Title Enrolled Subjects Set
    Arm/Group Description According to the crossover design, all the enrolled subjects received both NAC formulations based on the randomization schedule.Two single doses of 600 mg of NAC (one with test and one with reference formulation) were administered to each volunteer in two subsequent study periods (morning of day 1), separated by a wash-out interval of at least 5 days.
    Period Title: Overall Study
    STARTED 48
    COMPLETED 48
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Enrolled Subjects Set
    Arm/Group Description According to the crossover design, all the enrolled subjects received both NAC formulations based on the randomization schedule. Two single doses of 600 mg of NAC (one with test and one with reference formulation) were administered to each volunteer in two subsequent study periods (morning of day 1), separated by a wash-out interval of at least 5 days.
    Overall Participants 48
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    48
    100%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.6
    (8.6)
    Sex: Female, Male (Count of Participants)
    Female
    25
    52.1%
    Male
    23
    47.9%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    47
    97.9%
    More than one race
    0
    0%
    Unknown or Not Reported
    1
    2.1%
    Region of Enrollment (participants) [Number]
    Switzerland
    48
    100%

    Outcome Measures

    1. Primary Outcome
    Title Cmax of NAC After Single Dose Administration of Test and Reference
    Description Cmax is the maximum concentration level of the drug reached in plasma.
    Time Frame 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)

    Outcome Measure Data

    Analysis Population Description
    PK set: all randomised subjects who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned treatment comparisons, with no major deviations that could affect the PK results.
    Arm/Group Title Test Reference
    Arm/Group Description N-acetylcysteine (NAC) 600 mg uncoated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h. N-acetylcysteine (NAC) 600 mg film-coated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
    Measure Participants 48 48
    Mean (Standard Deviation) [ng/mL]
    2804.38
    (899.47)
    3215.63
    (1382.02)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Test, Reference
    Comments
    Type of Statistical Test Equivalence
    Comments The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.
    Statistical Test of Hypothesis p-Value 0.0136
    Comments p value for treatment effect
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Geometric means ratio
    Estimated Value 89.81
    Confidence Interval (2-Sided) 94.12%
    82.82 to 97.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title AUC0-t of NAC After Single Dose Administration of Test and Reference
    Description AUC0-t is the Area under the concentration-time curve from time zero to time t, calculated with the linear trapezoidal summation from time 0 to the last measurable data point.
    Time Frame 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)

    Outcome Measure Data

    Analysis Population Description
    PK set: all randomised subjects who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned treatment comparisons, with no major deviations that could affect the PK results.
    Arm/Group Title Test Reference
    Arm/Group Description N-acetylcysteine (NAC) 600 mg uncoated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h. N-acetylcysteine (NAC) 600 mg film-coated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
    Measure Participants 48 48
    Mean (Standard Deviation) [ng/mL*h]
    10637.87
    (3100.94)
    11773.11
    (3775.43)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Test, Reference
    Comments
    Type of Statistical Test Equivalence
    Comments The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.
    Statistical Test of Hypothesis p-Value 0.0047
    Comments
    Method ANOVA
    Comments p value for treatment effect
    Method of Estimation Estimation Parameter Geometric means ratio
    Estimated Value 90.79
    Confidence Interval (2-Sided) 94.12%
    85.25 to 96.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title AUC0-∞ of NAC After Single Dose Administration of Test and Reference
    Description AUC0-∞ is the area under the concentration-time curve extrapolated to infinity, calculated, if feasible, as AUC0-t + Ct/λz, where Ct is the last measurable drug concentration.
    Time Frame 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)

    Outcome Measure Data

    Analysis Population Description
    PK set: all randomised subjects who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned treatment comparisons, with no major deviations that could affect the PK results.
    Arm/Group Title Test Reference
    Arm/Group Description N-acetylcysteine (NAC) 600 mg uncoated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h. N-acetylcysteine (NAC) 600 mg film-coated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
    Measure Participants 48 48
    Mean (Standard Deviation) [ng/mL*h]
    12586.17
    (3577.24)
    13739.43
    (4190.59)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Test, Reference
    Comments
    Type of Statistical Test Equivalence
    Comments The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.
    Statistical Test of Hypothesis p-Value 0.0095
    Comments p value for treatment effect
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Geometric means ratio
    Estimated Value 91.86
    Confidence Interval (2-Sided) 94.12%
    86.45 to 97.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Tmax of NAC After Single Dose Administration of Test and Reference
    Description time to achieve the maximum concentration level of the drug in plasma.
    Time Frame 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Test Reference
    Arm/Group Description N-acetylcysteine (NAC) 600 mg uncoated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h. N-acetylcysteine (NAC) 600 mg film-coated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
    Measure Participants 48 48
    Median (Full Range) [hours]
    1.00
    1.00
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Test, Reference
    Comments
    Type of Statistical Test Equivalence
    Comments The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.
    Statistical Test of Hypothesis p-Value 0.5050
    Comments
    Method Friedman test
    Comments
    5. Secondary Outcome
    Title t1/2 of NAC After Single Dose Administration of Test and Reference
    Description Half-life (t1/2) is the time to halve the plasma concentration level of the drug.
    Time Frame 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)

    Outcome Measure Data

    Analysis Population Description
    PK set: all randomised subjects who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned treatment comparisons, with no major deviations that could affect the PK results.
    Arm/Group Title Test Reference
    Arm/Group Description N-acetylcysteine (NAC) 600 mg uncoated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h. N-acetylcysteine (NAC) 600 mg film-coated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
    Measure Participants 48 48
    Mean (Standard Deviation) [hours]
    14.11
    (4.16)
    13.59
    (2.69)
    6. Secondary Outcome
    Title Lambda Zeta of NAC After Single Dose Administration of Test and Reference
    Description Lambda zeta is the terminal elimination rate constant. Individual estimate of the terminal elimination rate constant can be calculated using log-linear regression of the terminal portions of the plasma concentration-versus-time curves.
    Time Frame 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)

    Outcome Measure Data

    Analysis Population Description
    PK set: all randomised subjects who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned treatment comparisons, with no major deviations that could affect the PK results.
    Arm/Group Title Test Reference
    Arm/Group Description N-acetylcysteine (NAC) 600 mg uncoated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h. N-acetylcysteine (NAC) 600 mg film-coated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
    Measure Participants 48 48
    Mean (Standard Deviation) [1/h]
    0.05
    (0.01)
    0.05
    (0.01)
    7. Secondary Outcome
    Title Frel of NAC After Single Dose Administration of Test and Reference
    Description Frel is the relative bioavailability, calculated as ratio AUC0-t (test)/ AUC0-t (reference)
    Time Frame 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)

    Outcome Measure Data

    Analysis Population Description
    PK set: all randomised subjects who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned treatment comparisons, with no major deviations that could affect the PK results.
    Arm/Group Title Enrolled Subjects Set
    Arm/Group Description According to the crossover design, all the enrolled subjects received both NAC formulations based on the randomization schedule.
    Measure Participants 48
    Mean (Standard Deviation) [percentage]
    92.82
    (18.05)

    Adverse Events

    Time Frame From the beginning of screening days ( day -21 ) up to Final Visit (Day 2).
    Adverse Event Reporting Description
    Arm/Group Title Test - Reference Reference - Test
    Arm/Group Description N-acetylcysteine (NAC) 600 mg uncoated tablet (single dose) followed by NAC 600 mg film-coated tablet (single dose) N-acetylcysteine: The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h. N-acetylcysteine (NAC) 600 mg film-coated tablet (single dose) followed by NAC 600 mg uncoated tablet (single dose) N-acetylcysteine: The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
    All Cause Mortality
    Test - Reference Reference - Test
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/48 (0%) 0/48 (0%)
    Serious Adverse Events
    Test - Reference Reference - Test
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/48 (0%) 0/48 (0%)
    Other (Not Including Serious) Adverse Events
    Test - Reference Reference - Test
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/48 (8.3%) 2/48 (4.2%)
    Gastrointestinal disorders
    Nausea 1/48 (2.1%) 1 1/48 (2.1%) 1
    Abdominal discomfort 0/48 (0%) 0 1/48 (2.1%) 1
    Vomiting 1/48 (2.1%) 1 0/48 (0%) 0
    Nervous system disorders
    Dizziness 2/48 (4.2%) 2 0/48 (0%) 0
    Headache 2/48 (4.2%) 2 0/48 (0%) 0

    Limitations/Caveats

    Limitations and Caveats not specified

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Isabella Salerio, PhD
    Organization Zambon S.p.A.
    Phone +3902665241
    Email clinicaltrials@zambongroup.com
    Responsible Party:
    Zambon SpA
    ClinicalTrials.gov Identifier:
    NCT02265224
    Other Study ID Numbers:
    • Z7169J02
    • CRO-PK-14-286
    First Posted:
    Oct 15, 2014
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Oct 1, 2021