Dyslipidemias
Conditions
Brief summary
To evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A
Detailed description
Phase 1 to evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A. Which is designed as two cohort, single-sequence, paralle, open label, multiple oral dosing.
Interventions
DRUGYYC506-T
single administration
DRUGYYC506-A
single administration
DRUGYYC506-T + YYC506-A
concomotant administration
DRUGYYC506-A + YYC506-T
concomotant administration
Sponsors
Yooyoung Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
two-cohort, single-sequence, parallel, open label, multiple oral dosing study.
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Over 19 ages healty men * Over 50.0kg, 18.0kg/m2 ≤ BMI ≤30.0kg/m2 * Men who dont have congenital disease and other cronic disease need to be cared etc.
Exclusion criteria
* Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN) * Men who have drunken or eatten something including carffeine within 24 hours before etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokietic parameters administration: Cmax | Until 48 hours | YYC506-T, YYC506-A, and concomitant administration Cmax |
| Pharmacokietic parameters administration: AUC | Until 48 hours | YYC506-T, YYC506-A, and concomitant administration AUC |
Countries
South Korea
Outcome results
None listed