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

NCT06623526 | Completed Phase 1

• 1 other identifier: YHP2401-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteers

Keywords

pharmacokinetic interactions; Drug-Drug Interaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  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]

  0-96 hours

• Time of Maximum observed plasma concentration [Tmax]

  0-96 hours

• Apparent Terminal Elimination Half-life [t1/2]

  0-96 hours

Study Arms (2)

Sequence Group 1

EXPERIMENTAL

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

Drug: YHR2402; Drug: YHR2402+YHR2403

Sequence Group 2

EXPERIMENTAL

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

Drug: YHR2402; Drug: YHR2402+YHR2403

Interventions

YHR2402 DRUG

Test Drug: YHR2402

Sequence Group 1; Sequence Group 2

YHR2402+YHR2403 DRUG

Test Drug: YHR2402+YHR2403

Sequence Group 1; Sequence Group 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Study Officials

• Mingul Kim

  Jeonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two-way crossover

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: October 4, 2024
• Primary Completion: November 6, 2024
• Study Completion: November 11, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)