Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien Under Fasting Conditions

This study has been completed.

First Received: May 24, 2008 Last Updated: December 11, 2008 History of Changes

Sponsor:	Mutual Pharmaceutical Company, Inc.
Information provided by:	Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:	NCT00684814

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Zolpidem Tartrate	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Official Title:	A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioequivalence of a Test Tablet Formulation of Zolpidem Tartrate 10 mg, to an Equivalent Dose of Ambien in Healthy Adult Subjects.

Resource links provided by NLM:

Drug Information available for: Zolpidem

U.S. FDA Resources

Further study details as provided by Mutual Pharmaceutical Company, Inc.:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Enrollment:	31
Study Start Date:	May 2004
Study Completion Date:	May 2004
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental One tablet containing 10 mg test product to be administered at hour 0 on Day 1 of each test period.	Drug: Zolpidem Tartrate
B: Active Comparator One Ambien tablet containing 10 mg reference drug to be administered at hour 0 on Day 1 of each test period.	Drug: Zolpidem Tartrate

Eligibility

Ages Eligible for Study:	18 Years to 54 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Sex: Male or Female; similar proportions
Age: At least 18 years
Weight: must be 15% of ideal weight for height and frame
Subjects must be in good health and physical condition as determined by medical history
Subjects must read and sign the Consent Form

Exclusion Criteria:

History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months.
History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
History of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
History of treatment for asthma within the past five (5) yars.
History of mental depression.
History of pulmonary disease.
History of sleep apnea.
Females who are pregnant or lactating.
History of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative.

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Recalls, Market Withdrawals and Safety Alerts This link exits the ClinicalTrials.gov site

Daily Med - Posting of Recently Submitted Labeling to the FDA This link exits the ClinicalTrials.gov site

URL Pharma Generic Division This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mutual Pharmaceutical Company, Inc. ( Vice President R&D )
Study ID Numbers:	04064
Study First Received:	May 24, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00684814 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mutual Pharmaceutical Company, Inc.:

equivalency
Therapeutic equivalency

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 November 20, 2009