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

NCT00939367 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-06-28

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

DRUG

Zolpidem Tartrate Tablets 10 mg

DRUG

'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-24
Primary Completion
2007-05-02
Completion
2007-05-02

Countries

  • India

Study Locations

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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 NCT00939367 on ClinicalTrials.gov