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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07470125

Enrollment

Registered

2026-03-13

Start date

2026-06-23

Completion date

2026-07-20

Last updated

2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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

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.

Interventions

DRUGYHP2511

Test drug: YHP2511, Comparator: YHP2511A

DRUGYHP2511A

Test drug: YHP2511, Comparator: YHP2511A

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

South Korea

Contacts

PRINCIPAL_INVESTIGATORSeoung Hyun Kang

H Plus Yangji Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026