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OpenTrials
Completed

NCT Number: NCT07470125

Bioequivalence (BE) Study Between YHP2511 and YHP2511A in Healthy 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

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Key information

Conditions

Healthy Subjects

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, 08779, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

YHP2511

Drug

Test drug: YHP2511, Comparator: YHP2511A

YHP2511A

Drug

Test drug: YHP2511, Comparator: YHP2511A

Primary outcomes

  1. 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

  2. Maximum plasma concentration [Cmax]

    Time frame: Pitavastatin: 0-48 hours, Total Ezetimibe: 0-72 hours

    Maximum plasma concentration [Cmax] of - Pitavastatin & Total Ezetimibe

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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