Status:
COMPLETED
Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Under Fasting Conditions
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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® (z...
Detailed Description
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® (z...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00684814
Start Date
May 1 2004
End Date
May 1 2004
Last Update
April 20 2012
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