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

NCT00939536 | Completed Phase 1 Results

• 1 other identifier: US/05/003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

• Objective:
• To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: Ambien® Tablets 10 mg (Reference Listed Drug) manufactured by Sanofi- Synthelabo Inc. under fasting conditions in 24 healthy, adult, human subjects.
• Study Design:
• Open label, randomized, two-period, two-treatment, two-sequence single dose crossover design.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  The maximum or peak concentration that the drug reaches in the plasma

  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.

• Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]

  The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)

  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-∞)

  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.

  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.

Study Arms (2)

Torrent's Zolpidem Tartrate Tablets 10 mg

EXPERIMENTAL

Normal Healthy Human Subjects receiving Torrent's Zolpidem Tartrate Tablets 10 mg

Drug: Zolpidem Tartrate Tablets 10 mg

Sanofi-Synthelabo's Ambien® 10 mg Tablets

ACTIVE COMPARATOR

Normal Healthy Human Subjects receiving Sanofi-Synthelabo's Ambien® 10 mg Tablets

Drug: Zolpidem Tartrate Tablets 10 mg

Interventions

Zolpidem Tartrate Tablets 10 mg DRUG

Sanofi-Synthelabo's Ambien® 10 mg Tablets; Torrent's Zolpidem Tartrate Tablets 10 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects in the range of 18 - 45 years of age.
• Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart. (Appendix A)
• 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), including vitamins and minerals for 15 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.

You may not qualify if:

• 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.
• 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.
• History of psychiatric disorder or history of suicide attempt.
• 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 ten (10) hours prior to study drug administration the day of each study period and for four (4) additional hours each, post dose.
• 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.
• Any contraindication to blood sampling.
• 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.
• Use of xanthine-containing beverages or food 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 allergic reactions to zolpidem or other related drugs.
• History of drug abuse in the past one year.

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

Study Sites (1)

Accutest Research Laboratories Pvt. Ltd.

Mumbai, Maharashtra, India

Location

MeSH Terms

Interventions

Zolpidem

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kedar Joshi
• Organization: Accutest Research Laboratories Pvt. Ltd.

+91 22 27780718

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 15, 2009
• Study Start: June 1, 2005
• Primary Completion: June 1, 2005
• Study Completion: July 1, 2005
• Last Updated: October 22, 2013
• Results First Posted: October 22, 2013

Record last verified: 2013-08

Locations

IN (1)