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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06623526

Enrollment

Registered

2024-10-02

Start date

2024-10-04

Completion date

2024-11-11

Last updated

2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

pharmacokinetic interactions, Drug-Drug Interaction

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.

Interventions

DRUGYHR2402

Test Drug: YHR2402

DRUGYHR2402+YHR2403

Test Drug: YHR2402+YHR2403

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

two-way crossover

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026