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
Sponsored by: Mutual Pharmaceutical Company, Inc.
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.
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
Minimum age: 18 Years.
Maximum age: 54 Years.
- 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
- Subjects must read and sign the Consent Form
- History of treatment for alcoholism, substance abuse, or drug abuse within past 24
- History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other
- History of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including
- 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
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