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

NCT ID: NCT04874142

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-20

Study Completion Date

2020-03-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyslipidemias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two-cohort, single-sequence, parallel, open label, multiple oral dosing study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A Group

Two cohort, single sequence

Group Type EXPERIMENTAL

YYC506-T

Intervention Type DRUG

single administration

YYC506-T + YYC506-A

Intervention Type DRUG

concomotant administration

B Group

Two cohort, single sequence

Group Type EXPERIMENTAL

YYC506-A

Intervention Type DRUG

single administration

YYC506-A + YYC506-T

Intervention Type DRUG

concomotant administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

YYC506-T

single administration

Intervention Type DRUG

YYC506-A

single administration

Intervention Type DRUG

YYC506-T + YYC506-A

concomotant administration

Intervention Type DRUG

YYC506-A + YYC506-T

concomotant administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yooyoung Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Min Kyu Park, PhD

Role: STUDY_CHAIR

ChungBuk National Unviersity Hospital.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ChungBuk National University Hospital

Cheongju-si, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

YYPCT_YYC506_P1_DDI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.