Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien Under Fasting Conditions
Information source: Mutual Pharmaceutical Company, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Therapeutic Equivalency
Intervention: Zolpidem Tartrate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mutual Pharmaceutical Company, Inc.
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.
Clinical Details
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.
Study design: Other, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 54 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Recalls, Market Withdrawals and Safety Alerts Daily Med - Posting of Recently Submitted Labeling to the FDA URL Pharma Generic Division
Starting date: May 2004
Ending date: May 2004
Last updated: May 27, 2008
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