clinical trial · NCT00909753
Ursodiol 500 mg Tablets Under Fed Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 92
HealthyUrsodiolUrso Forte™
brief 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.
started
Sep 1, 2006
primary completion
Oct 1, 2006
completion
Oct 1, 2006
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500 mg Tablets Under Fed Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol