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

NCT ID: NCT04874129

Last Updated: 2021-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2021-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

ramdomized, open-label, single-dose, two-way crossover study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A Group

Two-way Crossover

Group Type OTHER

YYC506-T and YYC506-A (phase 1)

Intervention Type DRUG

Comparator

YYC506 (phase 2)

Intervention Type DRUG

Test

B Group

Two-way Crossover

Group Type OTHER

YYC506 (phase 1)

Intervention Type DRUG

Test

YYC506-T and YYC506-A (phase 2)

Intervention Type DRUG

Comparator

Interventions

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YYC506-T and YYC506-A (phase 1)

Comparator

Intervention Type DRUG

YYC506 (phase 1)

Test

Intervention Type DRUG

YYC506-T and YYC506-A (phase 2)

Comparator

Intervention Type DRUG

YYC506 (phase 2)

Test

Intervention Type DRUG

Other Intervention Names

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Comparator Test Comparator Test

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yooyoung Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Kyu Park, PhD

Role: STUDY_CHAIR

Chungbuk National University Hosipital.

Locations

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Chungbuk National Unviersity Hosipital

Cheongju-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YYPCT_YYC506_102

Identifier Type: -

Identifier Source: org_study_id

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