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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ursodiol 500 MG; Drug: Urso Forte 500Mg Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03512821

2016-4053

Details and patient eligibility

About

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

Full description

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

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, non-smoking, male and female subjects, 18 years of age or older
• BMI ≥ 19.0 and ≤ 30.0 kg/m2.
• Females who participate in this study will be of chilbearing or nonchildbearing potential

Exclusion criteria

• Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Ursodiol 500mg tablets

Experimental group

Description:

Ursodiol 500mg tablets followed by Urso Forte 500mg tablets

Treatment:

Drug: Ursodiol 500 MG

Urso Forte 500mg tablets

Active Comparator group

Description:

Urso forte 500mg tablets followed by Ursodiol 500mg tablets

Treatment:

Drug: Urso Forte 500Mg Tablet