An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate Bioequivalence Between YHP2205 and YHR2401 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- YHP2205
- Conditions
- Healthy Volunteers
- Sponsor
- Yuhan Corporation
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Area under the plasma drug concentration-time curve [AUCt]
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Sequence Group B
30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8
Intervention: YHP2205
Sequence Group A
30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8
Intervention: YHP2205
Sequence Group A
30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8
Intervention: YHR2401
Sequence Group B
30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8
Intervention: YHR2401
Outcomes
Primary Outcomes
Area under the plasma drug concentration-time curve [AUCt]
Time Frame: 0-36 hours
Area under the plasma drug concentration-time curve \[AUCt\] of Edoxaban
Maximum plasma concentration [Cmax]
Time Frame: 0-36 hours
Maximum plasma concentration \[Cmax\] of Edoxaban
Secondary Outcomes
- 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)