Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions
Not Applicable
Completed
- Conditions
- Infection
- Registration Number
- NCT00601315
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion Criteria
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to clarithromycin or any other macrolide antibiotic.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Bioequivalence Baseline, Two period, Seven day washout
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MDS Pharma Services
🇺🇸Phoenix, Arizona, United States