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

Yuhan Corporation28 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dyslipidemia Type 2 Diabetes Mellitus

Interventions

YHR1705DRUG

Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.

YHR1706DRUG

Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.

YHR1705+YHR1706DRUG

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

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2 * Who has not suffered from clinically significant disease * Provision of signed written informed consent Exclusion Criteria: * History of and clinically significant disease * A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs * Administration of other investigational products within 3 months prior to the first dosing * Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Locations (1)

Chonbuk National University Hospital

Jeonju, South Korea

Outcomes

Primary Outcomes

YHR1705, YHR1706 AUCtau

AUCtau

Time frame: 0 - 24hours

YHR1705, YHR1706 Css, max

Css,max

Time frame: 0 - 24hours

Data from ClinicalTrials.gov

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