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.”

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.

Study Type: Interventional

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

Study Primary Completion Date: May 2004

Intervention(s) in this Clinical Trial

• Drug: Zolpidem Tartrate

Arms, Groups and Cohorts in this Clinical Trial

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

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 54 Years

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

Lead Sponsor: Mutual Pharmaceutical Company, Inc.

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00684814

Study ID Number: 04064

ClinicalTrials.gov Identifier: NCT00684814

Health Authority: United States: Institutional Review Board

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