Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506

YooYoung Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Dyslipidemias

Treatments: Drug: YYC506-T and YYC506-A (phase 1); Drug: YYC506 (phase 2); Drug: YYC506 (phase 1); Drug: YYC506-T and YYC506-A (phase 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04874129

YYPCT_YYC506_102

Details and patient eligibility

About

To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

A Group

Other group

Description:

Two-way Crossover

Treatment:

Drug: YYC506 (phase 2)

Drug: YYC506-T and YYC506-A (phase 1)

B Group

Other group

Description:

Two-way Crossover

Treatment:

Drug: YYC506-T and YYC506-A (phase 2)

Drug: YYC506 (phase 1)