MedTrace Logo

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

NCT00939536 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-10-22

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Zolpidem Tartrate Tablets 10 mg

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2005-06-30
Completion
2005-07-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00939536 on ClinicalTrials.gov