NCT02300688

Bioequivalence Study to Compare the Pharmacokinetics of Besifovir in Healthy Adult Volunteers

An Open Label, Randomized, 2-sequence, 2-period, Single-dose Cross-over Study to Compare the Pharmacokinetics of Besifovir in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: IlDong Pharmaceutical Co Ltd · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

After administration of besifovir preparations different from each other to healthy subjects, the investigators evaluate equivalence of bioavailability of LB80331.

Detailed description

The purpose of this study is to evaluate equivalence of bioavailability of LB80331 preparations different. Following the randomly allocated sequence group administer the relevant test drug for 1 time according to the determined schedule of Treatment A and Treatment B in each of the periods.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Treatment A	administration of 1 time administration of the test drug (Treatment A)
DRUG	Treatment B	administration of 1 time administration of the reference drug (Treatment B)

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-11-25
• Last updated: 2016-01-13