Healthy Volunteers
Conditions
Keywords
Pharmacokinetics, Bioequivalence
Brief summary
An open-label, randomized, single-dose, oral administration, 2-sequence, 2- period, crossover study to evaluate bioequivalence between YHP2305 and YHR2404 in healthy subjects
Detailed description
Subjects in group A will be administered comparator and YHP2305 by crossover design on day 1, 8. Subjects in group B will be administered YHP2305 and comparator by crossover design on day 1, 8.
Interventions
DRUGYHP2305
Test drug: YHP2305 Comparator: YHR2404
DRUGYHR2404
Test drug: YHP2305 comparator: YHR2404
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 over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2 * Those who express their voluntary consent to participate in the trial by signing a written consent * Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma drug concentration-time curve [AUCt] | 0-36 hours |
| Maximum plasma concentration [Cmax] | 0-36 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed