Bioequivalence Study Between YHP2508C and YHR2603 in Healthy Subjects

NCT07584304 — Phase 1, Completed, 46 participants, Yuhan Corporation

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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

Registry	NCT07584304
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: quadruple, treatment
Enrollment	46 (Actual)
Sponsor	Yuhan Corporation (Industry)
Conditions	Healthy Subjects
Interventions	YHP2508C, YHR2603 (Drug)
Dates	start 2026-07-10, primary completion 2026-09-23, completion 2026-09-23, first posted 2026-05-13, last updated 2026-10-01
Locations	1 site in South Korea

-Summary

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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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
A(RTRT)	Experimental	Drug: YHP2508C; Drug: YHR2603	22 subjects, Cross-over, Single dose YHR2603 on period 1 and 3, Single dose of YHP2508C on period 2 and 4.
B(TRTR)	Experimental	Drug: YHP2508C; Drug: YHR2603	22 subjects, Cross-over, Single dose YHP2508C on period 1 and 3, Single dose of YHR2603 on period 2 and 4.

YHP2508C (Drug): Test drug
YHR2603 (Drug): Comparator drug

+Outcome measures

Primary outcomes

Area under the plasma drug concentration-time curve [AUCt] [0-72 hours]: Area under the plasma drug concentration-time curve \[AUCt\] of Amlodipine, Telmisartan \& Chlorthalidone
Maximum plasma concentration [Cmax] [0-72 hours]: Maximum plasma concentration \[Cmax\] of Amlodipine, Telmisartan \& Chlorthalidone

Secondary outcomes

Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] [0-72 hours]: Area under the plasma drug concentration-time curve from time 0 to infinity \[AUCinf\] of Amlodipine, Telmisartan \& Chlothalidone
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] [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
Time of peak concentration [Tmax] [0-72 hours]: Time of peak concentration \[Tmax\] of Amlodipine, Telmisartan \& Chlorthalidone
Terminal phase of half-life [t1/2] [0-72 hours]: Terminal phase of half-life \[t1/2\] of Amlodipine, Telmisartan \& Chlorthalidone

+Eligibility

Sex: All, ages: 19 Years to 54 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Gimpo Woori Hospital	Gimpo-si, Gyeonggi-do	South Korea

+Investigators

GIMPO WOORI HOSPITAL, Principal investigator, 11, Gamam-ro, Gimpo-si, Gyeonggi-do, Republic of Korea