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

An Open-label, Randomized, Fasting, Single-Crossover Study to Compare the Pharmacokinetic Interactions and Safety of YHR2402 Monotherapy and YHR2402 and YHR2403 Co-Administration in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: YHR2402; Drug: YHR2402+YHR2403

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Jeonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence Group 1; 13 subjects, Cross-over, Single dose of YHR2402 on day 1, Co-Administration of YHR2402 and YHR2403 on day 15	Drug: YHR2402; Test Drug: YHR2402; Drug: YHR2402+YHR2403; Test Drug: YHR2402+YHR2403
Experimental: Sequence Group 2; 13 subjects, Cross-over, Co-Administration of YHR2402 and YHR2403 on day 1, Single dose of YHR2402 on day 15	Drug: YHR2402; Test Drug: YHR2402; Drug: YHR2402+YHR2403; Test Drug: YHR2402+YHR2403

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Mingul Kim, Jeonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2024
• Primary Completion (Actual): November 6, 2024
• Study Completion (Actual): November 11, 2024

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: pharmacokinetic interactions; Drug-Drug Interaction
• Other Study ID Numbers: YHP2401-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No