Bioequivalence (BE) Study Between YHP2205 and YHR2401 in Healthy Volunteers

NCT06775522 | Completed Phase 1

• 1 other identifier: YHP2205-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Bioequivalence

Outcome Measures

Primary Outcomes (2)

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

  Area under the plasma drug concentration-time curve \[AUCt\] of Edoxaban

  0-36 hours

• Maximum plasma concentration [Cmax]

  Maximum plasma concentration \[Cmax\] of Edoxaban

  0-36 hours

Secondary Outcomes (4)

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

  0-36 hours

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

  0-36 hours

• Time of peak concentration [Tmax]

  0-36 hours

• Terminal phase of half-life [t1/2]

  0-36 hours

Study Arms (2)

Sequence Group A

EXPERIMENTAL

30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8

Drug: YHP2205; Drug: YHR2401

Sequence Group B

EXPERIMENTAL

30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8

Drug: YHP2205; Drug: YHR2401

Interventions

YHP2205 DRUG

Test drug: YHP2205 Comparator: YHR2401

Sequence Group A; Sequence Group B

YHR2401 DRUG

Test drug: YHP2205 Comparator: YHR2401

Sequence Group A; Sequence Group B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who are 19 years old or older at the screening visit
• Those whose weight is \> 60kg and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
• Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
• Those who express their voluntary consent to participate in the trial by signing a written consent

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.
• Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Bumin Hospital

Seoul, Gangseo-gu, 07590, South Korea

Location

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: Crossover Assignment two-way crossover

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 15, 2025
• Study Start: January 11, 2025
• Primary Completion: January 20, 2025
• Study Completion: January 21, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)