Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00840411
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test population of 66 adult subjects under fasting conditions.
- Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Clarithromycin (test) First Clarithromycin ER 500 mg tablets - Biaxin® XL (reference) First BIAXIN® XL 500 mg tablets -
- Primary Outcome Measures
Name Time Method Cmax - Maximum Observed Concentration Blood samples collected over 36 hour period Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) Blood samples collected over 36 hour period Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration Blood samples collected over 36 hour period Bioequivalence based on AUC0-t
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gateway Medical Research
🇺🇸Saint Charles, Missouri, United States