NCT03235362

A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706

A Phase 1, Randomized, Open-label, Multiple-dose, 3-treatment, 6-sequence, 3-period Crossover Clinical Trial to Investigate the Safety and Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers

Detailed description

This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive days. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.

Conditions

• Dyslipidemia
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	YHR1705	Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.
DRUG	YHR1706	Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.
DRUG	YHR1705+YHR1706	Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.

Timeline

• Start date: 2017-08-07
• Primary completion: 2017-09-19
• Completion: 2017-09-19
• First posted: 2017-08-01
• Last updated: 2017-11-01

Locations

1 site across 1 country: South Korea