Dyslipidemia, Type 2 Diabetes Mellitus
Conditions
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 washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.
Interventions
DRUGYHR1705
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.
DRUGYHR1706
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.
DRUGYHR1705+YHR1706
Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| YHR1705, YHR1706 AUCtau | 0 - 24hours | AUCtau |
| YHR1705, YHR1706 Css, max | 0 - 24hours | Css,max |
Countries
South Korea
Outcome results
None listed