NCT03034486

The Pharmacokinetics of D565 and the Drug Effect of D565 on Pharmacokinetic Characteristics of D930

A Single Sequence, 3-period, Multiple-dose Study to Evaluate the Pharmacokinetics of D565 and the Drug Effect of D565 on Pharmacokinetic Characteristics of D930 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a single sequence, 3-period, multiple-dose study to evaluate the pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of D930 in healthy male volunteers.

Detailed description

This study is a single sequence, 3-period, multiple-dose study to evaluate the pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of D930 in healthy male volunteers. Subjects will receive D565 just one time on period 1 for evaluate the pharmacokinetics. And afterward, subjects will receive multiple dose of D930 for 9 days, and D565 with D930 for 9 days to evaluate the drug effect on period 2 and 3. When period 1 finished, there are 3 days of washout period, but between period 2 and 3, there is no washout period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	D930, D565	Period 1: D565 administered 1 time for one day/ Period 2: D930 administered 3 time per day for 9 days/ Period 3: D565(1 time per day) with D930(3 time per day) administered for 9days

Timeline

• Start date: 2017-02-17
• Primary completion: 2017-03-17
• Completion: 2017-03-20
• First posted: 2017-01-27
• Last updated: 2017-07-31

Locations

1 site across 1 country: South Korea