NCT03512808

A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions

Detailed description

A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ursodiol 500 MG	Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
DRUG	Urso Forte 500Mg Tablet	Urso forte 500mg tablets followed by Ursodiol 500mg tablets

Timeline

• Start date: 2017-06-01
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2018-05-01
• Last updated: 2018-05-07

Locations

1 site across 1 country: Canada