Dyslipidemias
Conditions
Brief summary
To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A
Detailed description
Phase 1 to evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A. Which is designed as ramdomized, oral, single dose, two-way crossover.
Interventions
Comparator
Test
Comparator
Test
Sponsors
Study design
Intervention model description
ramdomized, open-label, single-dose, two-way crossover study
Eligibility
Inclusion criteria
* Over 19 ages healthy men * Over 50.0kg, 18.0kg/m2 ≤ BMI ≤ 30.0kg/m2 * Men who don't 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 caffeine within 24 hours before. etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters: Cmax | Until 48 hours | Cmax |
| Pharmacokinetic parameters: AUC | Until 48 hours | YYC506-T, YYC506-A, YYC506 AUC |
Countries
South Korea