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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dyslipidemia, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: YHR1705
* Drug: YHR1706
* Drug: YHR1705+YHR1706


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3. | Drug: YHR1705<br>* Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.<br>Drug: YHR1706<br>* Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.<br>Drug: YHR1705+YHR1706<br>* Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.<br>|
| Experimental: 2<br>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3. | Drug: YHR1705<br>* Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.<br>Drug: YHR1706<br>* Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.<br>Drug: YHR1705+YHR1706<br>* Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.<br>|
| Experimental: 3<br>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3. | Drug: YHR1705<br>* Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.<br>Drug: YHR1706<br>* Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.<br>Drug: YHR1705+YHR1706<br>* Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.<br>|
| Experimental: 4<br>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3. 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. | Drug: YHR1705<br>* Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.<br>Drug: YHR1706<br>* Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.<br>Drug: YHR1705+YHR1706<br>* Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.<br>|
| Experimental: 5<br>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3. | Drug: YHR1705<br>* Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.<br>Drug: YHR1706<br>* Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.<br>Drug: YHR1705+YHR1706<br>* Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.<br>|
| Experimental: 6<br>5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3. | Drug: YHR1705<br>* Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.<br>Drug: YHR1706<br>* Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.<br>Drug: YHR1705+YHR1706<br>* Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| YHR1705, YHR1706 AUCtau | AUCtau | 0 - 24hours | 
| YHR1705, YHR1706 Css, max | Css,max | 0 - 24hours |