Clinical Trial to Evaluate the PK Interactions of YHR2402 Monotherapy and YHR2402 and YHR2403 Co-Administration in Healthy Volunteers

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: YHR2402+YHR2403; Drug: YHR2402

Study type: Interventional

Funder types: Industry

Identifiers

NCT06623526

YHP2401-101

Details and patient eligibility

About

An open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetic interactions and safety after co-administration of YHR2402 and YHR2403 compared to the administration of YHR2402 independently in healthy subjects

Full description

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

"YHR2402" and "YHR2402"+"YHR2403" will be administered to Subjects in group 1 by crossover design on day 1, 15

"YHR2402"+"YHR2403" and "YHR2402" will be administered to Subjects in group 2 by crossover design on day 1, 15.

Enrollment: 26 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Those who are 19 years old and under 55 years old 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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26 participants in 2 patient groups

Sequence Group 1

Experimental group

Description:

13 subjects, Cross-over, Single dose of YHR2402 on day 1, Co-Administration of YHR2402 and YHR2403 on day 15

Treatment:

Drug: YHR2402+YHR2403

Drug: YHR2402

Sequence Group 2

Experimental group

Description:

13 subjects, Cross-over, Co-Administration of YHR2402 and YHR2403 on day 1, Single dose of YHR2402 on day 15

Treatment:

Drug: YHR2402+YHR2403

Drug: YHR2402