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Completed

NCT Number: NCT04225052

Clinical Trial to Evaluate the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers

A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and pharmacokinetics of YHP1903 in healthy volunteers

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk national university hospital

Jeonju, Jeollabuk-do, 54907, South Korea

About this study

32 healthy subjects wil be randomized one of 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP1903" by cross-over design on day1, 8.

Subjects in group 2 will be administered "YHP1903" and "comparator" by cross-over design on day1, 8.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
  • Acceptable medical history, physical examination, laboratory tests and EKG, during screening
  • Subjects who has signed a written informed consent voluntarily,prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Exclusion criteria

  • History of clinically significant disease
  • Sitting blood pressure meeting the following criteria at screening:
  • 140 ≤ systolic blood pressure ≤90 (mmHg)
  • 90 ≤ diastolic blood pressure ≤ 60 (mmHg)
  • Have AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit or Total bilirubin > 2.0 mg/dl at the time of screening
  • Volunteers considered not eligible for the clinical trial by the investigator
  • Administration of other investigational products within 6 month prior to the first dosing.

Treatment and study plan

YHP1903

Drug

YHP1903 Tab. 1mg

Champix

Drug

Comparator Champix Tab. 1mg

Primary outcomes

  1. AUCt

    Time frame: 0-96 hours

    AUCt of Varenicline

  2. Cmax

    Time frame: 0-96 hours

    Cmax of Varenicline

Secondary outcomes

  1. AUCinf

    Time frame: 0-96 hours

    AUCinf of Varenicline

  2. Tmax

    Time frame: 0-96 hours

    Tmax of Varenicline

  3. t1/2

    Time frame: 0-96 hours

    t1/2 of Varenicline

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Collaborators

  • Chonbuk National University Hospital

Registry information

Official study title

A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2020
Registry last updated
Jan 23, 2020

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.

Published trials that share one or more normalized conditions with this study.