Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting Conditions
Summary
The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under fed conditions.
Timeline
- Start
- 2003-09
- Primary completion
- 2003-09
- Completion
- 2003-09
Outcome
Met primary endpoint
registry Ratio of Least Squares Means 97.70 (90% CI 93.19 to 102.43) NCT00836901 ↗
registry Ratio of Least Squares Means 99.28 (90% CI 97.09 to 101.53) NCT00836901 ↗
registry Ratio of Least Squares Means 97.64 (90% CI 96.12 to 99.19) NCT00836901 ↗
registry Ratio of Least Squares Means 94.59 (90% CI 85.64 to 104.47) NCT00836901 ↗
registry Ratio of Least Squares Means 94.44 (90% CI 87.83 to 101.54) NCT00836901 ↗
registry Ratio of Least Squares Means 94.08 (90% CI 87.19 to 101.52) NCT00836901 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 400 mg | — |
| Subject | clavulanic acid | Small molecule | 57 mg | — |
Indications
No indication recorded.