Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions

This study has been completed.

First Received: January 15, 2008 Last Updated: February 5, 2008 History of Changes

Sponsor:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00602719

Purpose

The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Condition	Intervention
Insomnia	Drug: Zolpidem

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zolpidem Tartrate Tablets 10 MG Under Fed Conditions

Resource links provided by NLM:

Drug Information available for: Zolpidem

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Two period, Seven day washout ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	March 2004
Study Completion Date:	March 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to Zolpidem or any comparable or similar product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602719

Locations

United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Alan K Copa

PRACS Institute, Ltd.

More Information

No publications provided

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	ZOLP-02
Study First Received:	January 15, 2008
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00602719 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Zolpidem
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
GABA Agonists
Hypnotics and Sedatives

Physiological Effects of Drugs
Central Nervous System Depressants
GABA Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010