Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | April 2003 |
| End Date: | May 2003 |
A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of 250 mg Clarithromycin Tablets Under Fasting Conditions
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.
clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin
tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.
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.
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