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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-04

Study Completion Date

2024-11-11

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

two-way crossover

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence Group 1

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

Group Type EXPERIMENTAL

YHR2402

Intervention Type DRUG

Test Drug: YHR2402

YHR2402+YHR2403

Intervention Type DRUG

Test Drug: YHR2402+YHR2403

Sequence Group 2

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

Group Type EXPERIMENTAL

YHR2402

Intervention Type DRUG

Test Drug: YHR2402

YHR2402+YHR2403

Intervention Type DRUG

Test Drug: YHR2402+YHR2403

Interventions

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YHR2402

Test Drug: YHR2402

Intervention Type DRUG

YHR2402+YHR2403

Test Drug: YHR2402+YHR2403

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes