Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506
Phase 1
- Conditions
- Dyslipidemias
- Interventions
- Drug: YYC506 (phase 1)Drug: YYC506-T and YYC506-A (phase 1)Drug: YYC506 (phase 2)Drug: YYC506-T and YYC506-A (phase 2)
- Registration Number
- NCT04874129
- Lead Sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A Group YYC506 (phase 2) Two-way Crossover B Group YYC506 (phase 1) Two-way Crossover A Group YYC506-T and YYC506-A (phase 1) Two-way Crossover B Group YYC506-T and YYC506-A (phase 2) Two-way Crossover
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters: Cmax Until 48 hours Cmax
Pharmacokinetic parameters: AUC Until 48 hours YYC506-T, YYC506-A, YYC506 AUC
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chungbuk National Unviersity Hosipital
🇰🇷Cheongju-si, Korea, Republic of
Chungbuk National Unviersity Hosipital🇰🇷Cheongju-si, Korea, Republic of