Studies in Fasted 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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00939536
• Date of registration: 13/07/2009
• Primary sponsor: Torrent Pharmaceuticals Limited
• Public title: Studies in Fasted 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
• Scientific title: Studies in Fasted 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
• Date of first enrolment: July 2009
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00939536
• Study type: Interventional
• Study design: N/A

Countries of recruitment

India

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male and female subjects in the range of 18 - 45 years of age.

2. Body weight within ± 15% of ideal weight as related to height and body frame
according to Life Insurance Corporation (LIC) Chart. (Appendix A)

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), including
vitamins and minerals for 15 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:

1. Requiring medication for any ailment including enzyme-modifying drugs Use of any
drugs known to induce or inhibit hepatic drug metabolism (e.g.s, inducers:
barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors:
SSRIs, cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil,
fluoroquinolones, antihistamines) within 30 days prior to administration of the study
medication.

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. History of psychiatric disorder or history of suicide attempt.

5. Participation in a clinical drug study or bioequivalence study 90 days prior to
present study.

6. History of malignancy or other serious diseases.

7. Refusal to abstain from food for ten (10) hours prior to study drug administration
the day of each study period and for four (4) additional hours each, post dose.

8. Refusal to abstain from water for one (1) hour prior to study drug administration the
day of each study period and for two (2) additional hour, post dosing.

9. Any contraindication to blood sampling.

10. Refusal to abstain from smoking or consumption of tobacco products 24 hours before
dosing until last sample collection of each period. Habituation of tobacco
necessitating uninterrupted tobacco consumption.

11. Use of xanthine-containing beverages or food for 48 hours prior to each drug dose.

12. Blood donation 90 days prior to the commencement of the study.

13. Subjects with positive HIV tests, HbsAg or Hepatitis-C tests.

14. Known history of allergic reactions to zolpidem or other related drugs.

15. History of drug abuse in the past one year.

16. 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 2 weeks prior to administration of study
medication, except for topical products without systemic absorption.

17. Pregnant and lactating women.

- At the time of screening, prior to enrollment, presence of pregnancy will be
confirmed by urine pregnancy test.

- Female subjects not confirming to using birth control measures, from the date of
screening till the completion of the second period of the study. Abstinence,
barrier methods (condom, diaphragm, etc.) are acceptable. Use of hormonal
contraceptives either oral or implants will not be acceptable.

18. Female subjects whose menstruation cycle coincides with the study periods.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Zolpidem Tablets

Primary Outcome(s)

Bioequivalence

Secondary ID(s)

US/05/003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors