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

NCT ID: NCT03235362

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2017-09-19

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.

Conditions

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Dyslipidemia Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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.

Group Type EXPERIMENTAL

YHR1705

Intervention Type DRUG

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

YHR1706

Intervention Type DRUG

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

YHR1705+YHR1706

Intervention Type DRUG

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

2

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.

Group Type EXPERIMENTAL

YHR1705

Intervention Type DRUG

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

YHR1706

Intervention Type DRUG

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

YHR1705+YHR1706

Intervention Type DRUG

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

3

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.

Group Type EXPERIMENTAL

YHR1705

Intervention Type DRUG

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

YHR1706

Intervention Type DRUG

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

YHR1705+YHR1706

Intervention Type DRUG

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

4

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.

Group Type EXPERIMENTAL

YHR1705

Intervention Type DRUG

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

YHR1706

Intervention Type DRUG

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

YHR1705+YHR1706

Intervention Type DRUG

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

5

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.

Group Type EXPERIMENTAL

YHR1705

Intervention Type DRUG

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

YHR1706

Intervention Type DRUG

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

YHR1705+YHR1706

Intervention Type DRUG

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

6

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.

Group Type EXPERIMENTAL

YHR1705

Intervention Type DRUG

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

YHR1706

Intervention Type DRUG

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

YHR1705+YHR1706

Intervention Type DRUG

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

Interventions

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YHR1705

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

Intervention Type DRUG

YHR1706

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

Intervention Type DRUG

YHR1705+YHR1706

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

Intervention Type DRUG

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mingul Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YH14755-103

Identifier Type: -

Identifier Source: org_study_id