clinical trial · NCT00909610
Ursodiol Tablets 500 mg Under Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 80
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 fasting conditions.
started
Dec 1, 2006
primary completion
Jan 1, 2007
completion
Jan 1, 2007
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 Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol