ClinicalTrials.gg
RecruitingNCT07912840Updated Nov 3, 2026

Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects

A Phase 1 interventional study of YHP2508B and YHR2602 in Healthy Subjects (HS), sponsored by Yuhan Corporation. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Yuhan Corporation · Phase 1, Interventional, and Treatment

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
19 Years to 54 Years
Sex
All
01

Study summary

An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508B and YHR2602 in healthy subjects.

Read the detailed description

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

Subjects in group 1 will be administered "YHR2602" and "YHP2508B" 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.

02

Conditions studied

  • Healthy Subjects (HS)

Keywords

  • Pharmacokinetics
  • Bioequivalence
03

In context

Lead sponsor

Yuhan Corporation is the lead sponsor of 110 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Those who have participated in a bioequivalence study or other clinical trials and have been administered 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 breathfeeding
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    A(RTRT)

    22 subjects, Cross-over, Single dose YHR2602 on period 1 and 3, Single dose of YHP2508B on period 2 and 4.

    Drug: YHP2508B · Drug: YHR2602

  • Experimental
    B(TRTR)

    22 subjects, Cross-over, Single dose YHP2508B on period 1 and 3, Single dose of YHR2602 on period 2 and 4.

    Drug: YHP2508B · Drug: YHR2602

Interventions

  • DrugYHP2508B

    Test drug

  • DrugYHR2602

    Comparator drug

06

What researchers measure

Primary outcomes

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

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

    Time frame: 0-72 hours

  2. Maximum plasma concentration [Cmax]

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

    Time frame: 0-72 hours

Secondary outcomes

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

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

    Time frame: 0-72 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]

    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 \& Chlothalidone

    Time frame: 0-72 hours

  3. Time of peak concentration [Tmax]

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

    Time frame: 0-72 hours

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

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

    Time frame: 0-72 hours

07

Study locations

1 of 1 sites recruiting
  • Gimpo Woori Hospital
    Gimpo-si, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07912840
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Oct 16, 2026
Primary completion
Jan 26, 2027 (estimated)
Completion
Jan 26, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Jungwook Lee, MS
Contact
clinicaltrials@yuhan.co.kr
82-2-828-0504
Hyeonsoo Park, MD
principal investigator · Gimpo Woori Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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