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 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.
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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