Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers

An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate Bioequivalence Between YHP2205 and YHR2401 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: YHP2205; Drug: YHR2401

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07590
    • Bumin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence Group A; 30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8	Drug: YHP2205; Test drug: YHP2205; Drug: YHR2401; comparator: YHR2401
Experimental: Sequence Group B; 30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8	Drug: YHP2205; Test drug: YHP2205; Drug: YHR2401; comparator: YHR2401

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]	Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Edoxaban	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]	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	0-36 hours
Time of peak concentration [Tmax]	Time of peak concentration [Tmax] of Edoxaban	0-36 hours
Terminal phase of half-life [t1/2]	Terminal phase of half-life [t1/2] of Edoxaban	0-36 hours

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Taegon Hong, Bumin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): July 6, 2024

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 7, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 10, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Bioequivalence
• Other Study ID Numbers: YHP2205-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No