The Effect of Food on the Bioavailability of Glipizide
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sandoz
- Enrollment
- 18
- Primary Endpoint
- Bioequivalence based on AUC and Cmax
Study Overview
Brief Summary
To demonstrate the effect of food on the bioavailability of Glipizide.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
3
10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.
Intervention: 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast. (Drug)
1
10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.
Intervention: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast. (Drug)
2
10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.
Intervention: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast. (Drug)
Outcomes
Primary Outcomes
Bioequivalence based on AUC and Cmax
Time Frame: 15 days
Secondary Outcomes
No secondary outcomes reported