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
1 other identifier
interventional
44
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2026
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2026
CompletedFirst Posted
Study publicly available on registry
May 13, 2026
CompletedStudy Start
First participant enrolled
July 10, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2026
Study Completion
Last participant's last visit for all outcomes
September 15, 2026
May 13, 2026
May 1, 2026
2 months
May 7, 2026
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under the plasma drug concentration-time curve [AUCt]
Area under the plasma drug concentration-time curve \[AUCt\] of Amlodipine, Telmisartan \& Chlorthalidone
0-72 hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration \[Cmax\] of Amlodipine, Telmisartan \& Chlorthalidone
0-72 hours
Secondary Outcomes (4)
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/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
0-72 hours
Time of peak concentration [Tmax]
0-72 hours
Terminal phase of half-life [t1/2]
0-72 hours
Study Arms (2)
A(RTRT)
EXPERIMENTAL22 subjects, Cross-over, Single dose YHR2603 on period 1 and 3, Single dose of YHP2508C on period 2 and 4.
B(TRTR)
EXPERIMENTAL22 subjects, Cross-over, Single dose YHP2508C on period 1 and 3, Single dose of YHR2603 on period 2 and 4.
Interventions
Eligibility Criteria
You may qualify if:
- BMI 18-30 kg/m2
- Those without clinically significant congenital or chronic diseases
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
GIMPO WOORI HOSPITAL
11, Gamam-ro, Gimpo-si, Gyeonggi-do, Republic of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2026
First Posted
May 13, 2026
Study Start (Estimated)
July 10, 2026
Primary Completion (Estimated)
September 15, 2026
Study Completion (Estimated)
September 15, 2026
Last Updated
May 13, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share