Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets

• 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 Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.

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

Details

• Lead Sponsor: Mutual Pharmaceutical Company, Inc.
• Treatments: Polystyrene sulfonic acid; 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

• 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, pulmonary disease, sleep apnea

• females who are pregnant or lactating

• history of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative

• conditions upon screening which might contraindicate or require that caution be used in the administration of zolpidem tartrate, including sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg; heart rate less than 50 beats per minute after a 5-minute rest in a seated position

• inability to read and/or sign the consent form

• treatment with any other investigation drug during the four (4) weeks prior to the initial dosing for this study

• subjects who have donated blood within four (4) weeks prior to the initial dosing for this study

• subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.) Three (3) months abstinence is required.