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

YooYoung Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Dyslipidemias

Treatments: Drug: YYC506-A; Drug: YYC506-T + YYC506-A; Drug: YYC506-T; Drug: YYC506-A + YYC506-T

Study type: Interventional

Funder types: Industry

Identifiers

NCT04874142

YYPCT_YYC506_P1_DDI

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

A Group

Experimental group

Description:

Two cohort, single sequence

Treatment:

Drug: YYC506-T

Drug: YYC506-T + YYC506-A

B Group

Experimental group

Description:

Two cohort, single sequence

Treatment:

Drug: YYC506-A + YYC506-T

Drug: YYC506-A