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.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
80
Ursodiol Tablets, 500 mg
Urso Forte™ Tablets, 500 mg
Pharma Medica Research Inc.
Toronto, Ontario, Canada
Cmax - Maximum Observed Concentration - for Total Ursodiol
Bioequivalence based on Cmax
Time frame: Blood samples collected over 72 hour period
AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours - for Total Ursodiol
Bioequivalence based on AUC0-72
Time frame: Blood samples collected over 72 hour period
Cmax for Baseline Corrected Total Ursodiol
Bioequivalence based on Cmax
Time frame: Blood samples collected over 72 hour period
AUC0-72 for Baseline Corrected Total Ursodiol
Bioequivalence based on AUC0-72
Time frame: Blood samples collected over 72 hour period
Cmax for Unconjugated Ursodiol
Bioequivalence based on Cmax
Time frame: Blood samples collected over 72 hour period
AUC0-72 for Unconjugated Ursodiol
Bioequivalence based on AUC0-72
Time frame: Blood samples collected over 72 hour period
Cmax for Unconjugated Ursodiol - Baseline Corrected
Bioequivalence based on Cmax
Time frame: Blood samples collected over 72 hour period
AUC0-72 for Unconjugated Ursodiol - Baseline Corrected
Bioequivalence based on AUC0-72
Time frame: Blood samples collected over 72 hour period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.