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

NCT07470125 | Recruiting Phase 1

• 1 other identifier: YHP2511-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

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

  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]

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

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

Study Arms (2)

A (RT)

EXPERIMENTAL

30 subjects, Cross-over, Single dose YHP2511A on period 1, Single dose of YHP2511 on period 2

Drug: YHP2511; Drug: YHP2511A

B (TR)

EXPERIMENTAL

30 subjects, Cross-over, Single dose YHP2511 on period 1, Single dose of YHP2511A on period 2

Drug: YHP2511; Drug: YHP2511A

Interventions

YHP2511 DRUG

Test drug: YHP2511, Comparator: YHP2511A

A (RT); B (TR)

YHP2511A DRUG

Test drug: YHP2511, Comparator: YHP2511A

A (RT); B (TR)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, 08779, South Korea

RECRUITING

Study Officials

• Seoung Hyun Kang

  H Plus Yangji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujin Kim

CONTACT

82-2-828-0394; clinicaltrials@yuhan.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start (Estimated): June 23, 2026
• Primary Completion (Estimated): July 11, 2026
• Study Completion (Estimated): July 11, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)