Healthy Volunteers
Conditions
Keywords
Pharmacokinetics, Bioequivalence
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 crossover design on day 1, 8 Subjects in group 2 will be administered comparator and YHP2205 by crossover design on day 1, 8.
Interventions
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Crossover Assignment two-way crossover
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed