Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.
Detailed description
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study
Interventions
DRUGDWJ1458 (fasted)
Subjects take single dose of DWJ1458 on a fated condition
DRUGDWJ1458 (fed)
Subjects take single dose of DWJ1458 after high-fat diet
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 19 to 55 years * BMI 18.5≥ and ≤27.0 kg/m² * Female subjects must be menopause or surgically infertility. * Male subjects must consent to contraception for at least 60 days after the study period and the final administration of the study drug. * Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.
Exclusion criteria
* History of hypersensitivity to investigational product * Participation in a clinical drug study or bioequivalence study 6 months prior to the present study * The subject who is judged to be unsuitable as a test subject in a screening test. * The subject who is judged to be unsuitable for participation in a clinical trial due to other reasons determined by the investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameter of DWJ1458: AUC0-t | 0 - 144 hours after dosing | Area under the plasma concentration-time curve from time 0 to time t |
| Pharmacokinetic parameter of DWJ1458: Cmax | 0 - 144 hours after dosing | Maximum plasma drug concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameter of DWJ1458: t1/2 | 0 - 144 hours after dosing | Elimination half-life |
| Pharmacokinetic parameter of DWJ1458: AUCinf | 0 - 144 hours after dosing | Area under the plasma concentration-time curve from drug administration to drug elimination |
| Pharmacokinetic parameter of DWJ1458: Cl/F | 0 - 144 hours after dosing | Apparent total clearance of drug from plasma after oral administration |
| Pharmacokinetic parameter of DWJ1458: Vd/F | 0 - 144 hours after dosing | Apparent volume of distribution after oral administration |
| Pharmacokinetic parameter of DWJ1458: Tmax | 0 - 144 hours after dosing | Time to reach maximum plasma concentration following drug administration |
Countries
South Korea
Outcome results
None listed