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

NCT ID: NCT00684814

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2004-05-31

Brief 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.

Detailed Description

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.

Thirty-eight healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zolpidem tartrate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, zolpidem tartrate (1 x 10 mg tablet) or a single oral dose of the reference formulation, Ambien® (1 x 10 mg tablet). After a 7 day washout period, on the morning of Day 8 after an overnight fast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 12 hours post dose at times sufficient to adequately define the pharmacokinetics of zolpidem tartrate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drugs and/or procedures. Blood pressure and pulse rate will be obtained prior to dosing and at 0.5, 1, 2, 4 and 12 hours post-dose. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Zolpidem Tartrate 10 mg Tablets

A single dose of zolpidem tartrate 10 mg administered after an overnight fast of at least 10 hours.

Group Type: EXPERIMENTAL

Zolpidem Tartrate 10 mg tablet

Intervention Type: DRUG

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

Zolpidem Tartrate (Ambien®) 10 mg Tablets

A single dose of Ambien® 10 mg administered after an overnight fast of at least 10 hours.

Group Type: EXPERIMENTAL

Zolpidem Tartrate 10 mg tablet (Ambien®)

Intervention Type: DRUG

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

Interventions

Zolpidem Tartrate 10 mg tablet

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

Intervention Type: DRUG

Zolpidem Tartrate 10 mg tablet (Ambien®)

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

Intervention Type: DRUG

Other Intervention Names

Ambien®, Sanofi-Synthelabo Inc.

Eligibility Criteria

Inclusion Criteria

• Sex: Male or Female; similar proportions of each preferred
• 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) years.
• 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.
• Treatment with any other investigational drug during the four weeks prior to the initial dosing of the study.
• Donation of blood within four weeks prior to the initial dosing of the study
• Smokers or subjects who use tobacco/nicotine products. Three months abstinence is required.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mutual Pharmaceutical Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Mutual Pharmaceutical Company, Inc.

Related Links

http://www.fda.gov/opacom/7alerts.html

Recalls, Market Withdrawals and Safety Alerts

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Daily Med - Posting of Recently Submitted Labeling to the FDA

Other Identifiers

04064

Identifier Type: -

Identifier Source: org_study_id