Status:
COMPLETED
Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Healthy
Therapeutic Equivalency
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 Ambien® (zolpidem tartrate tablet...
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 Ambien® (zolpidem tartrate tablet...
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
- 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, pulmonary disease, sleep apnea
- females who are pregnant or lactating
- history of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative
- conditions upon screening which might contraindicate or require that caution be used in the administration of zolpidem tartrate, including sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg; heart rate less than 50 beats per minute after a 5-minute rest in a seated position
- inability to read and/or sign the consent form
- treatment with any other investigation drug during the four (4) weeks prior to the initial dosing for this study
- subjects who have donated blood within four (4) weeks prior to the initial dosing for this study
- subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.) Three (3) 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
NCT00658541
Start Date
May 1 2004
End Date
May 1 2004
Last Update
May 3 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.