NCT02941731

Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics of HIP1403 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the bioequivalence after administration of HIP1403 and HGP0919 suspensions in healthy male volunteers.

Detailed description

A randomized, open-label, single dose, crossover clinical trial to investigate and compare the pharmacokinetics between HIP1403 and HGP0919 suspensions in healthy male volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HIP1403	Oseltamivir 6mg/mL
DRUG	HGP0919	Oseltamivir phosphate 6mg/mL

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2016-10-21
• Last updated: 2016-10-21

Locations

1 site across 1 country: South Korea