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

May 4, 2021 updated by: Yooyoung Pharmaceutical Co., Ltd.
To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Unviersity Hosipital

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 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.

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A Group
Two-way Crossover
Drug: YYC506-T and YYC506-A (phase 1)
Comparator
Other Names:
  • Comparator
Drug: YYC506 (phase 2)
Test
Other Names:
  • Test
Other: B Group
Two-way Crossover
Drug: YYC506 (phase 1)
Test
Other Names:
  • Test
Drug: YYC506-T and YYC506-A (phase 2)
Comparator
Other Names:
  • Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters: Cmax
Time Frame: Until 48 hours
Cmax
Until 48 hours
Pharmacokinetic parameters: AUC
Time Frame: Until 48 hours
YYC506-T, YYC506-A, YYC506 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 University Hosipital.

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)

January 7, 2021

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

July 31, 2021

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_102

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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