drugset / Trial / NCT00834756
Azithromycin 600 Mg Tablets, Fasting
RandomizedCrossoverOpen-labelOther
Summary
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in a test population of 36 adult subjects under fasting conditions.
Timeline
- Start
- 2002-09
- Primary completion
- 2002-10
- Completion
- 2002-10
Outcome
Met primary endpoint
registry Test/Ref Ratio of LS Means x 100 96.00 (90% CI 87.96 to 104.78) NCT00834756 ↗
registry Test/Ref Ratio of LS Means x 100 98.63 (90% CI 92.34 to 105.35) NCT00834756 ↗
registry Test/Ref Ratio of LS Means x 100 100.37 (90% CI 93.95 to 107.21) NCT00834756 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 600 mg | Oral |
Indications
No indication recorded.