Bioequivalence (BE) Study Between YHP2511 and YHP2511A in Healthy Volunteers

May 28, 2026 updated by: Yuhan Corporation

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of YHP2511 With YHP2511A in Healthy Adult Volunteers

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2511 and YHP2511A in healthy volunteers

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Subjects in group 1 will be administered "comparator" and "YHP2511" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2511" and "comparator" by crossover design on period 1, 2.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea, 08779
        • Recruiting
        • H Plus Yangji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 19 to 55 years at the time of screening visit.
  • Those whose weight is ≥ 50 kg (≥ 45 kg for females) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
  • Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
  • Those who express their voluntary consent to participate in the trial by signing a written consent

Exclusion Criteria:

  • Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
  • Others who are judged ineligible to participate in the trial by the principal investigator
  • Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A (RT)
30 subjects, Cross-over, Single dose YHP2511A on period 1, Single dose of YHP2511 on period 2
Drug: YHP2511
Test drug: YHP2511, Comparator: YHP2511A
Drug: YHP2511A
Test drug: YHP2511, Comparator: YHP2511A
Experimental: B (TR)
30 subjects, Cross-over, Single dose YHP2511 on period 1, Single dose of YHP2511A on period 2
Drug: YHP2511
Test drug: YHP2511, Comparator: YHP2511A
Drug: YHP2511A
Test drug: YHP2511, Comparator: YHP2511A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma drug concentration-time curve [AUCt]
Time Frame: Pitavastatin : 0-72 hours, Total Ezetimibe: 0-72 hours
Area under the plasma drug concentration-time curve [AUCt] of Pitavastatin & Total Ezetimibe
Pitavastatin : 0-72 hours, Total Ezetimibe: 0-72 hours
Maximum plasma concentration [Cmax]
Time Frame: Pitavastatin: 0-48 hours, Total Ezetimibe: 0-72 hours
Maximum plasma concentration [Cmax] of - Pitavastatin & Total Ezetimibe
Pitavastatin: 0-48 hours, Total Ezetimibe: 0-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: Seoung Hyun Kang, H Plus Yangji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 23, 2026

Primary Completion (Estimated)

July 11, 2026

Study Completion (Estimated)

July 11, 2026

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • YHP2511-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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