Ursodiol 500 mg Tablets Under Fed Conditions
Summary
The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference)after a single-dose in healthy subjects under fed conditions.
Timeline
- Start
- 2006-09
- Primary completion
- 2006-10
- Completion
- 2006-10
Outcome
Met primary endpoint
registry analysis (unspecified test); Ursodiol vs Urso Forte™; Geometric Test/Ref Ratio x 100 92.5 (90% CI 85.8 to 99.7) NCT00909753 ↗
registry analysis (unspecified test); Ursodiol vs Urso Forte™; Geometric Test/Ref Ratio x 100 95.5 (90% CI 92.2 to 98.9) NCT00909753 ↗
registry analysis (unspecified test); Ursodiol vs Urso Forte™; Geometric Test/Ref Ratio x 100 90.4 (90% CI 83.1 to 98.3) NCT00909753 ↗
registry analysis (unspecified test); Ursodiol vs Urso Forte™; Geometric Test/Ref Ratio x 100 90.5 (90% CI 85.5 to 95.9) NCT00909753 ↗
registry analysis (unspecified test); Ursodiol vs Urso Forte™; Geometric Test/Ref Ratio x 100 92.2 (90% CI 85.5 to 99.5) NCT00909753 ↗
registry analysis (unspecified test); Ursodiol vs Urso Forte™; Geometric Test/Ref Ratio x 100 95.0 (90% CI 91.3 to 98.7) NCT00909753 ↗
registry analysis (unspecified test); Ursodiol vs Urso Forte™; Geometric Test/Ref Ratio x 100 90.5 (90% CI 85.0 to 96.3) NCT00909753 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ursodeoxycholic Acid | Small molecule | 500 mg | — |
Indications
No indication recorded.