Status:

COMPLETED

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

Lead Sponsor:

Yuhan Corporation

Conditions:

Dyslipidemia

Type 2 Diabetes Mellitus

Eligibility:

MALE

19-55 years

Phase:

PHASE1

Brief 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 w...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 7 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 19 2017

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT03235362

Start Date

August 7 2017

End Date

September 19 2017

Last Update

November 1 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Chonbuk National University Hospital

Jeonju, South Korea