MedTrace Logo

Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Under Fasting Conditions

NCT00684814 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2012-04-20

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available reference drug product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions.

Conditions

  • Healthy

Interventions

DRUG

Zolpidem Tartrate 10 mg tablet

10 mg tablet administered after an overnight fast of at least 10 hours

DRUG

Zolpidem Tartrate 10 mg tablet (Ambien®)

10 mg tablet administered after an overnight fast of at least 10 hours

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2004-05-31
Completion
2004-05-31

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 NCT00684814 on ClinicalTrials.gov