To Demonstrate the Effect of Food on the Bioavailability of Glipizide
Phase 1
Completed
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.Drug: 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.
- Registration Number
- NCT00947024
- Lead Sponsor
- Sandoz
- Brief Summary
To demonstrate the effect of food on the bioavailability of Glipizide.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
Inclusion Criteria
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast. 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast. 3 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast. 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast. 2 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast. 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.
- Primary Outcome Measures
Name Time Method Bioequivalence based on AUC and Cmax 15 days
- Secondary Outcome Measures
Name Time Method