Bioequivalence Study betweenYHP2407 and YHR2502 in Healthy Subjects

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: YHR2502; Drug: YHP2407

Study type: Interventional

Funder types: Industry

Identifiers

NCT06926387

YHP2407-101

Details and patient eligibility

About

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2407 and YHR2502 in healthy volunteers

Full description

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

Subjects in group 1 will be administered "comparator" and "YHP2407" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2407" and "comparator" by crossover design on period 1, 2.

Enrollment: 43 patients

Sex: All

Ages: 19 to 64 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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43 participants in 2 patient groups

A(RT)

Experimental group

Description:

20 subjects, Cross-over, Single dose YHR2502 on period 1, Single dose of YHP2407 on period 2

Treatment:

Drug: YHP2407

Drug: YHR2502

B(TR)

Experimental group

Description:

20 subjects, Cross-over, Single dose of YHP2407 on period 1, Single dose of YHR2502 on period 2

Treatment:

Drug: YHP2407

Drug: YHR2502