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 10mg, Compared to an Equivalent Dose of Ambien in Healthy Adult Subjects”

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

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: May 2004

Intervention(s) in this Clinical Trial

• Drug: zolpidem tartrate
  • 10 mg tablet
• Drug: zolpidem tartrate
  • 10 mg tablet

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • One tablet containing 10mg test product to be administered at hour 0 on Day 1 of each test period
• Active Comparator: B
  • One Ambien tablet containing 10mg reference drug to be administered at hour 0 on Day 1 of each test period

Primary Measures

• Bioequivalence
  • Time Frame: two weeks
    Safety Issue?: No

Inclusion Criteria:

• male or female
• at least 18 years of age
• 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, complete physical examination, and laboratory tests, all within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation
• subjects must read and sign 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mutual Pharmaceutical Company, Inc.

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00658541

Study ID Number: 04065

ClinicalTrials.gov Identifier: NCT00658541

Health Authority: United States: Institutional Review Board

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