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Trial record 49 of 131 for:    ZOLPIDEM

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE July 13, 2009
First Posted Date  ICMJE July 15, 2009
Results First Submitted Date  ICMJE July 22, 2009
Results First Posted Date  ICMJE November 14, 2013
Last Update Posted Date June 28, 2018
Actual Study Start Date  ICMJE February 24, 2007
Actual Primary Completion Date May 2, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2013)
  • 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
  • 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)
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00939367 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Zolpidem Tartrate Tablets 10 mg
  • Drug: 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
Study Arms  ICMJE
  • Experimental: Test
    Torrent's Zolpidem TartrateTablets 10 mg
    Intervention: Drug: Zolpidem Tartrate Tablets 10 mg
  • Active Comparator: Reference
    Sanofi-Synthelabo Inc's Ambient® Tablets 10 mg
    Intervention: Drug: 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2018)
50
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2, 2007
Actual Primary Completion Date May 2, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00939367
Other Study ID Numbers  ICMJE US/05/004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Torrent Pharmaceuticals Limited
Study Sponsor  ICMJE Torrent Pharmaceuticals Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Torrent Pharmaceuticals Limited
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP