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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: YHR2402; Drug: YHR2402+YHR2403

• Registration Number: NCT06623526
• Lead Sponsor: Yuhan Corporation

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-09-30
• Study First Posted: 2024-10-02
• Study Start: 2024-10-04
• Status Verified: 2024-11
• Primary Completion: 2024-11-06
• Study Completion: 2024-11-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence Group 2	YHR2402	13 subjects, Cross-over, Co-Administration of YHR2402 and YHR2403 on day 1, Single dose of YHR2402 on day 15
Sequence Group 2	YHR2402+YHR2403	13 subjects, Cross-over, Co-Administration of YHR2402 and YHR2403 on day 1, Single dose of YHR2402 on day 15
Sequence Group 1	YHR2402	13 subjects, Cross-over, Single dose of YHR2402 on day 1, Co-Administration of YHR2402 and YHR2403 on day 15
Sequence Group 1	YHR2402+YHR2403	13 subjects, Cross-over, Single dose of YHR2402 on day 1, Co-Administration of YHR2402 and YHR2403 on day 15

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration [Cmax]	0-96 hours	of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine
Area under the plasma drug concentration-time curve [AUCt]	0-96 hours	of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine

Secondary Outcome Measures

Name	Time	Method
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]	0-96 hours	of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]	0-96 hours	of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine
Time of Maximum observed plasma concentration [Tmax]	0-96 hours	of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine
Apparent Terminal Elimination Half-life [t1/2]	0-96 hours	of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine

Trial Locations

Locations (1)

Jeonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of