Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: YHR2501; Drug: YHP2406

Study type: Interventional

Funder types: Industry

Identifiers

NCT07265167

YHP2406-102

Details and patient eligibility

About

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

Full description

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.

Enrollment: 63 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

A(RT)

Experimental group

Description:

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

Treatment:

Drug: YHP2406

Drug: YHR2501

B(TR)

Experimental group

Description:

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

Treatment:

Drug: YHP2406

Drug: YHR2501