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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235362
• Other study ID #: YH14755-103
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2017
• Last updated: October 30, 2017
• Start date: August 7, 2017
• Est. completion date: September 19, 2017

Study information

• Verified date: July 2017
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 19, 2017
• Est. primary completion date: September 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	YHR1705, YHR1706 AUCtau	AUCtau	0 - 24hours
Primary	YHR1705, YHR1706 Css, max	Css,max	0 - 24hours