NCT02529800

Investigating the Pharmacokinetic Characteristics of HIP1402 in Healthy Male Volunteers

A Randomized, Open-label, Single Dose, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetics Incorporating a Comparison of Fed/Fasted Pharmacokinetics of HIP1402 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To investigate the PK charateristics and the effect of food on the PK in healthy male volunteers who receive HIP1402 capsule in fed versus fasted condition

Detailed description

A randomized, open-label, single dose, three-way crossover clinical trial to investigate the pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of HIP1402 in healthy male volunteers

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HIP1402	Tamsulosin HCl 0.4mg
DRUG	HGP0412	Tamsulosin HCl 0.2mg

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-08-20
• Last updated: 2016-10-13