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

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mutual Pharmaceutical Company, Inc.
• Treatments: Zolpidem

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.