Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: YHP2305; Drug: YHR2404

Study type: Interventional

Funder types: Industry

Identifiers

NCT06613139

YHP2305-101

Details and patient eligibility

About

An open-label, randomized, single-dose, oral administration, 2-sequence, 2- period, crossover study to evaluate bioequivalence between YHP2305 and YHR2404 in healthy subjects

Full description

Subjects in group A will be administered comparator and YHP2305 by crossover design on day 1, 8.

Subjects in group B will be administered YHP2305 and comparator by crossover design on day 1, 8.

Enrollment: 34 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Those who are 19 years old or older at the screening visit
• Those whose weight is over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
• Those who express their voluntary consent to participate in the trial by signing a written consent
• Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Group A(RT)

Experimental group

Description:

17 subjects, Cross-over, Single dose of YHR2404 on day 1, Single dose of YHP2305 on day 8

Treatment:

Drug: YHR2404

Drug: YHP2305

Group B(TR)

Experimental group

Description:

17 subjects, Cross-over, Single dose of YHP2305 on day 1, Single dose of YHR2404 on day 8

Treatment:

Drug: YHR2404

Drug: YHP2305