Hypertension
Conditions
Brief summary
To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under non-fasting conditions.
Interventions
DRUGRamipril 10 mg Capsule (Sandoz)
DRUGAltace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 | 30 days |
Outcome results
None listed