Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A

Phase 1

Completed

• Conditions: Dyslipidemias
• Interventions: Drug: YYC506-T; Drug: YYC506-A; Drug: YYC506-A + YYC506-T; Drug: YYC506-T + YYC506-A

• 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.

Study Timeline

• Study Start: 2019-11-20
• Primary Completion: 2020-03-23
• Study Completion: 2020-03-23
• Status Verified: 2021-04
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-05-04
• Last Update Submitted: 2021-05-04
• Study First Posted: 2021-05-05
• Last Update Posted: 2021-05-05

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

Trial Locations

Locations (1)

ChungBuk National University Hospital; 🇰🇷 Cheongju-si, Korea, Republic of