To Demonstrate the Relative Bioavailability of Atenolol Tablets
Phase 1
Completed
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00913965
- Lead Sponsor
- Sandoz
- Brief Summary
To demonstrate the relative bioavailability of Atenolol tablets.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Atenolol Tablets 100 mg (Cord Laboratories) Atenolol Tablets 100 mg (Cord Laboratories) 2 Atenolol Tablets 100 mg (Stuart Pharmaceutical) Atenolol Tablets 100 mg (Stuart Pharmaceutical)
- Primary Outcome Measures
Name Time Method Bioequivalence based on AUC and Cmax 11 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does Atenolol's beta-1 adrenergic receptor antagonism influence hypertension pharmacodynamics in Phase 1 trials?
What are the comparative pharmacokinetic profiles of Cord vs. Stuart Atenolol 100 mg tablets in healthy volunteers?
Which CYP2D6 polymorphisms correlate with interindividual variability in Atenolol bioavailability for hypertension management?
What cardiovascular adverse event management strategies are recommended for Atenolol formulations in early-phase trials?
How do beta-blocker alternatives like Metoprolol compare to Atenolol in terms of bioavailability and efficacy for essential hypertension?