600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions
Summary
The objective of this study is to assess the bioequivalence between Amoxicillin and Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fasting conditions.
Timeline
- Start
- 2002-08
- Primary completion
- 2002-08
- Completion
- 2002-08
Outcome
Met primary endpoint
registry Test/Reference Ratio of Means x 100 100.91 (90% CI 95.82 to 106.26) NCT00840099 ↗
registry Test/Reference Ratio of the mean x 100 102.79 (90% CI 100.69 to 104.94) NCT00840099 ↗
registry Test/Reference Ratio of the mean x 100 102.75 (90% CI 100.62 to 104.93) NCT00840099 ↗
registry Test/Reference Ratio of the Mean x 100 100.47 (90% CI 93.28 to 108.20) NCT00840099 ↗
registry Ratio of the mean 104.15 (90% CI 96.35 to 112.58) NCT00840099 ↗
registry Ratio of the mean x 100 104.06 (90% CI 95.85 to 112.97) NCT00840099 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 600 mg | Oral |
| Subject | Clavulanate | Unknown | 42.9 mg | Oral |
Indications
No indication recorded.