Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects

NCT ID: NCT06920719

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-29

Study Completion Date

2025-07-09

Brief Summary

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A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers

Detailed Description

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

Subjects in group 1 will be administered "comparator" and "YHP2406" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.

Conditions

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Healthy Subject

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A(RT)

32 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2

Group Type EXPERIMENTAL

YHP2406

Intervention Type DRUG

Test drug: YHP2406, Comparator: YHR2501

YHR2501

Intervention Type DRUG

Test drug: YHP2406, Comparator: YHR2501

B(TR)

32 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2

Group Type EXPERIMENTAL

YHP2406

Intervention Type DRUG

Test drug: YHP2406, Comparator: YHR2501

YHR2501

Intervention Type DRUG

Test drug: YHP2406, Comparator: YHR2501

Interventions

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YHP2406

Test drug: YHP2406, Comparator: YHR2501

Intervention Type DRUG

YHR2501

Test drug: YHP2406, Comparator: YHR2501

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI 18-30 kg/m2
* Those without clinically significant congenital or chronic diseases

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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seoung Hyun Kang

Role: PRINCIPAL_INVESTIGATOR

H Plus Yangji Hospital

Locations

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H Plus Yangji Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YHP2406-101

Identifier Type: -

Identifier Source: org_study_id

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