Type 2 Diabetes
Conditions
Brief summary
To demonstrate the effect of food on the bioavailability of Glipizide.
Interventions
DRUG10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.
DRUG10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.
DRUG10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence based on AUC and Cmax | 15 days |
Outcome results
None listed