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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07584304

Enrollment

Registered

2026-05-13

Start date

2026-07-10

Completion date

2026-09-15

Last updated

2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Pharmacokinetics, Bioequivalence

Brief 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

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.

Interventions

DRUGYHP2508C

Test drug

DRUGYHR2603

Comparator drug

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 54 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

CONTACTJungwook Lee, MS

clinicaltrials@yuhan.co.kr82-2-828-0504

PRINCIPAL_INVESTIGATORGIMPO WOORI HOSPITAL

11, Gamam-ro, Gimpo-si, Gyeonggi-do, Republic of Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026