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Completed

NCT Number: NCT06623526

Clinical Trial to Evaluate the PK Interactions 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

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Key information

Conditions

Healthy Volunteers

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jeonbuk National University Hospital

Jeonju, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YHR2402

Drug

Test Drug: YHR2402

YHR2402+YHR2403

Drug

Test Drug: YHR2402+YHR2403

Primary outcomes

  1. Area under the plasma drug concentration-time curve [AUCt]

    Time frame: 0-96 hours

    of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine

  2. Maximum plasma concentration [Cmax]

    Time frame: 0-96 hours

    of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine

Secondary outcomes

  1. Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]

    Time frame: 0-96 hours

    of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine

  2. Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]

    Time frame: 0-96 hours

    of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine

  3. Time of Maximum observed plasma concentration [Tmax]

    Time frame: 0-96 hours

    of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine

  4. Apparent Terminal Elimination Half-life [t1/2]

    Time frame: 0-96 hours

    of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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