NCT02545829

Evaluating the Bioequivalence of HIP1302, HGP1406

A Randomized, Open, 2-way Cross-over, Single Dose Study to Evaluate and Compare Safety and Pharmacokinetics of the HIP1302 and HGP1406 (Tenofovir) in Healthy Korean Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the bioequivalence after administration of HIP1302 and HGP1406 in healthy male volunteers.

Detailed description

A Randomized, Open, 2-way cross-over, Single dose study to Evaluate and Compare Safety and Pharmacokinetics of the HIP1302 and HGP1406 in Healthy Korean Male Volunteers

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HIP1302	Tenofovir 292mg
DRUG	HGP1406	Tenofovir 300mg

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-09-10
• Last updated: 2016-10-13

Locations

1 site across 1 country: South Korea