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Two Period Crossover Studies in Fed 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

2014-08-27 03:20:47 | BioPortfolio

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 fed conditions in 30+2 healthy, adult, human subjects in a randomized crossover study.

- Study Design:

- Open label, randomized, two-period, two-treatment, two-sequence single dose crossover design.

Study Design

N/A

Conditions

Healthy

Intervention

Zolpidem Tartrate

Location

Accutest Research Laboratories Pvt. Ltd.
Mumbai
Maharashtra
India

Status

Completed

Source

Torrent Pharmaceuticals Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:47-0400

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