Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A
Phase 1
Completed
- Conditions
- Dyslipidemias
- Interventions
- Registration Number
- NCT04874142
- Lead Sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Group YYC506-A + YYC506-T Two cohort, single sequence A Group YYC506-T Two cohort, single sequence A Group YYC506-T + YYC506-A Two cohort, single sequence B Group YYC506-A Two cohort, single sequence
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ChungBuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of