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Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00939367
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : November 14, 2013
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited

Brief Summary:
Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.

Condition or disease Intervention/treatment Phase
Healthy Drug: Zolpidem Tartrate Tablets 10 mg Drug: 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg Phase 1

Detailed Description:
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Zolpidem Tartrate Tablets containing Zolpidem Tartrate 10 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Ambien® Tablets 10 mg containing Zolpidem Tartrate 10 mg (Reference , Sanofi-Synthelabo Inc) in Healthy Human Volunteers Under Fed Condition.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Two Period Crossover Studies in Fed Healthy, Normal Subjects to Compare the Single Dose Bioavailability of Torrent's Zolpidem Tartrate Tablets 10 mg and Sanofi-Synthelabo's Ambien® 10 mg Tablets
Actual Study Start Date : February 24, 2007
Actual Primary Completion Date : May 2, 2007
Actual Study Completion Date : May 2, 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test
Torrent's Zolpidem TartrateTablets 10 mg
Drug: Zolpidem Tartrate Tablets 10 mg
Active Comparator: Reference
Sanofi-Synthelabo Inc's Ambient® Tablets 10 mg
Drug: 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg



Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose. ]
    The maximum or peak concentration that the drug reaches in the plasma

  2. Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] [ Time Frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose. ]
    The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)

  3. The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞) [ Time Frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose. ]
    The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subjects who qualify for the study should meet the following inclusion criteria.

    1. Male and female subjects in the range of 18 - 45 years of age.
    2. Subjects having Body Mass Index (BMI) in a range of 18.5 to 24.9.
    3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and body temperature)
    4. Subjects with normal findings as determined by hematological tests, serum chemistry, urine analysis, ECG and X-ray.
    5. Willingness to follow the protocol requirement as evidenced by written, informed consent.
    6. Agreeing to, not using any medication prescription and over the counter medicines including vitamins and minerals for 14 days prior to study and during the course of the study.
    7. No history or presence of significant alcoholism or drug abuse in the past one year.
    8. Non-smokers, ex smokers and light smokers will be included. " Light smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers as someone who completely stopped smoking for at least 3 months.

Exclusion Criteria:

  • The subjects who qualify for the study should not meet the following exclusion criteria:

    1. Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day1.
    2. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
    3. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic diseases.
    4. Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
    5. History of malignancy or other serious diseases.
    6. Refusal to abstain from food for at least ten (10) hours prior to High Fat Breakfast and for additional four (4) hours post dose during each study period.
    7. Refusal to abstain from water for at least one (1) hour prior to study drug administration on each study period and for at least two (2) additional hours, post dosing.
    8. Any contraindication to blood sampling.
    9. Use of xanthine-containing beverages or food and grapefruit juice for 48 hours prior to each drug dose.
    10. Blood donation 90 days prior to the commencement of the study.
    11. Subjects with positive HIV tests, HbsAg or Hepatitis-C tests.
    12. Known history of hypersensitivity to zolpidem Tartrate or to any of the inactive ingredients in the formulation.
    13. Refusal to abstain from smoking or consumption of tobacco products 24 hours before dosing until last sample collection of each period.
    14. Pregnant and lactating women.
    15. Use of prescription medication within 14 days prior to administration of study medication or over the counter products (including natural food supplements,vitamins, garlic as a supplement) within 14 days prior to administration of study medication, except for topical products without systemic absorption.
    16. Female subjects whose menstruation cycle coincides with the study periods.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939367


Locations
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India
Accutest Research Laboratories Pvt. Ltd.
Mumbai, Maharashtra, India
Sponsors and Collaborators
Torrent Pharmaceuticals Limited

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Responsible Party: Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00939367     History of Changes
Other Study ID Numbers: US/05/004
First Posted: July 15, 2009    Key Record Dates
Results First Posted: November 14, 2013
Last Update Posted: June 28, 2018
Last Verified: October 2017
Additional relevant MeSH terms:
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Zolpidem
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action