Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: YHP2205; Drug: YHR2401

• Registration Number: NCT06359626
• Lead Sponsor: Yuhan Corporation

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

Detailed Description

60 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "YHP2205" and "comparator" by cross-over design on day 1, 8

Subjects in group 2 will be administered "comparator" and "YHP2205" by cross-over design on day 1, 8.

Study Timeline

• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-07
• Study First Posted: 2024-04-11
• Study Start: 2024-06-21
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-10
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence Group A	YHP2205	30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8
Sequence Group A	YHR2401	30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8
Sequence Group B	YHP2205	30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8
Sequence Group B	YHR2401	30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8

Primary Outcome Measures

Name	Time	Method
Area under the plasma drug concentration-time curve [AUCt]	0-36 hours	Area under the plasma drug concentration-time curve \[AUCt\] of Edoxaban
Maximum plasma concentration [Cmax]	0-36 hours	Maximum plasma concentration \[Cmax\] of Edoxaban

Secondary Outcome Measures

Name	Time	Method
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 from time 0 to infinity \[AUCinf\] of Edoxaban
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	Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity \[AUCt/AUCinf\] of Edoxaban
Time of peak concentration [Tmax]	0-36 hours	Time of peak concentration \[Tmax\] of Edoxaban
Terminal phase of half-life [t1/2]	0-36 hours	Terminal phase of half-life \[t1/2\] of Edoxaban

Trial Locations

Locations (1)

Bumin Hospital; 🇰🇷 Seoul, Korea, Republic of