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, 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 reference drug product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions.

Study Type: Interventional

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

Study Primary Completion Date: May 2004

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.

Intervention(s) in this Clinical Trial

• Drug: Zolpidem Tartrate 10 mg tablet
  • 10 mg tablet administered after an overnight fast of at least 10 hours
• Drug: Zolpidem Tartrate 10 mg tablet (Ambien®)
  • 10 mg tablet administered after an overnight fast of at least 10 hours

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Zolpidem Tartrate 10 mg Tablets
  • A single dose of zolpidem tartrate 10 mg administered after an overnight fast of at least 10 hours.
• Experimental: Zolpidem Tartrate (Ambien®) 10 mg Tablets
  • A single dose of Ambien® 10 mg administered after an overnight fast of at least 10 hours.

Primary Measures

• Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate
  • Time Frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
    Safety Issue?: No
• Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate
  • Time Frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
    Safety Issue?: No
• Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate
  • Time Frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
    Safety Issue?: No

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.

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 February 04, 2010

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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