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NCT Number: NCT07584304

Bioequivalence Study Between YHP2508C and YHR2603 in Healthy Subjects

An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508C and YHR2603 in healthy subjects

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Key information

Conditions

Healthy Subjects

Age range

19 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Subjects in group 1 will be administered "YHR2603" and "YHP2508C" by crossover design on periods 1 to 4.

Subjects in group 2 will be administered "YHP2508C" and " YHR2603" by crossover design on periods 1 to 4.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI 18-30 kg/m2
  • Those without clinically significant congenital or chronic diseases

Exclusion criteria

  • Those who have participated in a bioequivalence study or other clinical trials and have been administered investigational products within 6 months prior to the first administration.
  • Those 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

YHP2508C

Drug

Test drug

YHR2603

Drug

Comparator drug

Primary outcomes

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

    Time frame: 0-72 hours

    Area under the plasma drug concentration-time curve [AUCt] of Amlodipine, Telmisartan & Chlorthalidone

  2. Maximum plasma concentration [Cmax]

    Time frame: 0-72 hours

    Maximum plasma concentration [Cmax] of Amlodipine, Telmisartan & Chlorthalidone

Secondary outcomes

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

    Time frame: 0-72 hours

    Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Amlodipine, Telmisartan & Chlothalidone

  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: 0-72 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 Amlodipine, Telmisartan & Chlorthalidone

  3. Time of peak concentration [Tmax]

    Time frame: 0-72 hours

    Time of peak concentration [Tmax] of Amlodipine, Telmisartan & Chlorthalidone

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

    Time frame: 0-72 hours

    Terminal phase of half-life [t1/2] of Amlodipine, Telmisartan & Chlorthalidone

Study contacts

Contact information is provided by the study sponsor or research team.

Jungwook Lee, MS

CONTACT

[email protected]

82-2-828-0504

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

An Open-label, Randomized, Fasting, Single-dose, Oral Administration, 2-sequence, 4-period, Replicate Crossover Study to Evaluate Bioequivalence Between YHP2508C and YHR2603 in Healthy Subjects

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

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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