Hypertension
Conditions
Brief summary
To demonstrate the relative bioavailability of Atenolol tablets.
Interventions
DRUGAtenolol Tablets 100 mg (Cord Laboratories)
DRUGAtenolol Tablets 100 mg (Stuart Pharmaceutical)
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 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 | 11 days |
Outcome results
None listed