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OpenTrials
Completed

NCT Number: NCT04874142

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

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

Completed

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ChungBuk National University Hospital

Cheongju-si, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

YYC506-T

Drug

single administration

YYC506-A

Drug

single administration

YYC506-T + YYC506-A

Drug

concomotant administration

YYC506-A + YYC506-T

Drug

concomotant administration

Primary outcomes

  1. Pharmacokietic parameters administration: Cmax

    Time frame: Until 48 hours

    YYC506-T, YYC506-A, and concomitant administration Cmax

  2. Pharmacokietic parameters administration: AUC

    Time frame: Until 48 hours

    YYC506-T, YYC506-A, and concomitant administration AUC

Sponsors and collaborators

Lead sponsor

Yooyoung Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 5, 2021
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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