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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06359626
Other study ID # YHP2205-101
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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