Status:
COMPLETED
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions
Lead Sponsor:
Torrent Pharmaceuticals Limited
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 P...
Eligibility Criteria
Inclusion
- The subjects who qualify for the study should meet the following inclusion criteria.
- Male and female subjects in the range of 18 - 45 years of age.
- Subjects having Body Mass Index (BMI) in a range of 18.5 to 24.9.
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and body temperature)
- Subjects with normal findings as determined by hematological tests, serum chemistry, urine analysis, ECG and X-ray.
- Willingness to follow the protocol requirement as evidenced by written, informed consent.
- 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.
- No history or presence of significant alcoholism or drug abuse in the past one year.
- 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
- The subjects who qualify for the study should not meet the following exclusion criteria:
- Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day1.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic diseases.
- Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
- History of malignancy or other serious diseases.
- 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.
- 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.
- Any contraindication to blood sampling.
- Use of xanthine-containing beverages or food and grapefruit juice for 48 hours prior to each drug dose.
- Blood donation 90 days prior to the commencement of the study.
- Subjects with positive HIV tests, HbsAg or Hepatitis-C tests.
- Known history of hypersensitivity to zolpidem Tartrate or to any of the inactive ingredients in the formulation.
- Refusal to abstain from smoking or consumption of tobacco products 24 hours before dosing until last sample collection of each period.
- Pregnant and lactating women.
- 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.
- Female subjects whose menstruation cycle coincides with the study periods.
Key Trial Info
Start Date :
February 24 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00939367
Start Date
February 24 2007
End Date
May 2 2007
Last Update
June 28 2018
Active Locations (1)
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1
Accutest Research Laboratories Pvt. Ltd.
Mumbai, Maharashtra, India