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

Primary Purpose

Dyslipidemias

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YYC506-T
YYC506-A
YYC506-T + YYC506-A
YYC506-A + YYC506-T
Sponsored by
Yooyoung Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleAccepts 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.

Sites / Locations

  • ChungBuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A Group

B Group

Arm Description

Two cohort, single sequence

Two cohort, single sequence

Outcomes

Primary Outcome Measures

Pharmacokietic parameters administration: Cmax
YYC506-T, YYC506-A, and concomitant administration Cmax
Pharmacokietic parameters administration: AUC
YYC506-T, YYC506-A, and concomitant administration AUC

Secondary Outcome Measures

Full Information

First Posted
April 20, 2021
Last Updated
May 4, 2021
Sponsor
Yooyoung Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04874142
Brief Title
Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A
Official Title
Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yooyoung Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
two-cohort, single-sequence, parallel, open label, multiple oral dosing study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A Group
Arm Type
Experimental
Arm Description
Two cohort, single sequence
Arm Title
B Group
Arm Type
Experimental
Arm Description
Two cohort, single sequence
Intervention Type
Drug
Intervention Name(s)
YYC506-T
Intervention Description
single administration
Intervention Type
Drug
Intervention Name(s)
YYC506-A
Intervention Description
single administration
Intervention Type
Drug
Intervention Name(s)
YYC506-T + YYC506-A
Intervention Description
concomotant administration
Intervention Type
Drug
Intervention Name(s)
YYC506-A + YYC506-T
Intervention Description
concomotant administration
Primary Outcome Measure Information:
Title
Pharmacokietic parameters administration: Cmax
Description
YYC506-T, YYC506-A, and concomitant administration Cmax
Time Frame
Until 48 hours
Title
Pharmacokietic parameters administration: AUC
Description
YYC506-T, YYC506-A, and concomitant administration AUC
Time Frame
Until 48 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Kyu Park, PhD
Organizational Affiliation
ChungBuk National Unviersity Hospital.
Official's Role
Study Chair
Facility Information:
Facility Name
ChungBuk National University Hospital
City
Cheongju-si
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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