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Completed

NCT Number: NCT06359626

Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers

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Key information

Conditions

Healthy Volunteers

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bumin Hospital

Seoul, 07590, South Korea

About this study

60 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "YHP2205" and "comparator" by cross-over design on day 1, 8

Subjects in group 2 will be administered "comparator" and "YHP2205" by cross-over design on day 1, 8.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Those who are 19 years old or older at the screening visit
  • Those whose weight is > 60kg and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
  • Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
  • Those who express their voluntary consent to participate in the trial by signing a written consent

Exclusion criteria

  • Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
  • Others who are judged ineligible to participate in the trial by the principal investigator.
  • Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.

Treatment and study plan

YHP2205

Drug

Test drug: YHP2205

YHR2401

Drug

comparator: YHR2401

Primary outcomes

  1. Area under the plasma drug concentration-time curve [AUCt]

    Time frame: 0-36 hours

    Area under the plasma drug concentration-time curve [AUCt] of Edoxaban

  2. Maximum plasma concentration [Cmax]

    Time frame: 0-36 hours

    Maximum plasma concentration [Cmax] of Edoxaban

Secondary outcomes

  1. Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]

    Time frame: 0-36 hours

    Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Edoxaban

  2. Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]

    Time frame: 0-36 hours

    Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Edoxaban

  3. Time of peak concentration [Tmax]

    Time frame: 0-36 hours

    Time of peak concentration [Tmax] of Edoxaban

  4. Terminal phase of half-life [t1/2]

    Time frame: 0-36 hours

    Terminal phase of half-life [t1/2] of Edoxaban

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate Bioequivalence Between YHP2205 and YHR2401 in Healthy Subjects

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2024
Registry last updated
Nov 12, 2024

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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