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Bioequivalence Study of Zolpidem 10 mg Tablets Under Fed Conditions

NCT00779441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2008-10-24

No results posted yet for this study

Summary

The study compared the relative bioavailability (rate and extent of absorption) of 10 mg Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg Ambien® tablets distributed by Sanofi-Synthelabo, Inc. following single oral dose (1x10 mg tablet) in healthy adult volunteers administered under non-fasting conditions

Conditions

  • Healthy

Interventions

DRUG

Zolpidem 10mg tablets

Sponsors & Collaborators

  • Ranbaxy Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2005-09-30
Completion
2005-11-30

Countries

  • United States

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 NCT00779441 on ClinicalTrials.gov