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

May 4, 2021 updated by: Yooyoung Pharmaceutical Co., Ltd.
To evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Cheongju-si, Korea, Republic of
        • Chungbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A Group
Two cohort, single sequence
Drug: YYC506-T
single administration
Drug: YYC506-T + YYC506-A
concomotant administration
Experimental: B Group
Two cohort, single sequence
Drug: YYC506-A
single administration
Drug: YYC506-A + YYC506-T
concomotant administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokietic parameters administration: Cmax
Time Frame: Until 48 hours
YYC506-T, YYC506-A, and concomitant administration Cmax
Until 48 hours
Pharmacokietic parameters administration: AUC
Time Frame: Until 48 hours
YYC506-T, YYC506-A, and concomitant administration AUC
Until 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yooyoung Pharmaceutical Co., Ltd.

Investigators

  • Study Chair: Min Kyu Park, PhD, ChungBuk National Unviersity Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2019

Primary Completion (Actual)

March 23, 2020

Study Completion (Actual)

March 23, 2020

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YYPCT_YYC506_P1_DDI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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