Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06359626
• Other study ID #: YHP2205-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 27, 2024
• Est. completion date: July 6, 2024

Study information

• Verified date: May 2024
• Source: Yuhan Corporation
• Contact: Yujin Kim
• Phone: +8228280394
• Email: yjkim[@]yuhan.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 6, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• YHP2205
Test drug: YHP2205
• YHR2401
comparator: YHR2401

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma drug concentration-time curve [AUCt]	Area under the plasma drug concentration-time curve [AUCt] of Edoxaban	0-36 hours
Primary	Maximum plasma concentration [Cmax]	Maximum plasma concentration [Cmax] of Edoxaban	0-36 hours
Secondary	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
Secondary	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
Secondary	Time of peak concentration [Tmax]	Time of peak concentration [Tmax] of Edoxaban	0-36 hours
Secondary	Terminal phase of half-life [t1/2]	Terminal phase of half-life [t1/2] of Edoxaban	0-36 hours