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NCT04874142 Clinical Trial

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

Dyslipidemias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04874142
Other study ID # YYPCT_YYC506_P1_DDI
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 20, 2019
Est. completion date March 23, 2020

Study information
Verified date April 2021
Source Yooyoung Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A

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 information / eligibility
Status Completed
Enrollment 48
Est. completion date March 23, 2020
Est. primary completion date March 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• YYC506-T
single administration
• YYC506-A
single administration
• YYC506-T + YYC506-A
concomotant administration
• YYC506-A + YYC506-T
concomotant administration

Locations
Country Name City State
Korea, Republic of ChungBuk National University Hospital Cheongju-si

Sponsors (1)
Lead Sponsor Collaborator
Yooyoung Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokietic parameters administration: Cmax YYC506-T, YYC506-A, and concomitant administration Cmax Until 48 hours
Primary Pharmacokietic parameters administration: AUC YYC506-T, YYC506-A, and concomitant administration AUC Until 48 hours
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