Healthy
Conditions
Keywords
Antibiotic
Brief summary
To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.
Interventions
DRUGClarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)
DRUGBiaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 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 | 9 days |
Outcome results
None listed