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

Yuhan Corporation26 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

YHR2402DRUG

Test Drug: YHR2402

YHR2402+YHR2403DRUG

Test Drug: YHR2402+YHR2403

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Jeonbuk National University Hospital

Jeonju, South Korea