Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions
Condition: Healthy
Intervention: Zolpidem Tartrate Tablets 10 mg; 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
Intervention MeSH terms: Zolpidem
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

Eligibility 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.