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Completed

NCT Number: NCT06613139

Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers

An open-label, randomized, single-dose, oral administration, 2-sequence, 2- period, crossover study to evaluate bioequivalence between YHP2305 and YHR2404 in healthy subjects

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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

Subjects in group A will be administered comparator and YHP2305 by crossover design on day 1, 8.

Subjects in group B will be administered YHP2305 and comparator by crossover 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 over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
  • Those who express their voluntary consent to participate in the trial by signing a written consent
  • Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test

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.

Treatment and study plan

YHP2305

Drug

Test drug: YHP2305 Comparator: YHR2404

YHR2404

Drug

Test drug: YHP2305 comparator: YHR2404

Primary outcomes

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

    Time frame: 0-36 hours

  2. Maximum plasma concentration [Cmax]

    Time frame: 0-36 hours

Secondary outcomes

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

    Time frame: 0-36 hours

  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

  3. Time of peak concentration [Tmax]

    Time frame: 0-36 hours

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

    Time frame: 0-36 hours

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 YHP2305 and YHR2404 in Healthy Subjects

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Nov 15, 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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