A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics of Orally Administered DWJ1458 in Healthy Adults
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic parameter of DWJ1458: AUC0-t
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group 1
Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet.
Intervention: DWJ1458 (fasted) (Drug)
Group 1
Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet.
Intervention: DWJ1458 (fed) (Drug)
Group 2
Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition.
Intervention: DWJ1458 (fasted) (Drug)
Group 2
Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition.
Intervention: DWJ1458 (fed) (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic parameter of DWJ1458: AUC0-t
Time Frame: 0 - 144 hours after dosing
Area under the plasma concentration-time curve from time 0 to time t
Pharmacokinetic parameter of DWJ1458: Cmax
Time Frame: 0 - 144 hours after dosing
Maximum plasma drug concentration
Secondary Outcomes
- Pharmacokinetic parameter of DWJ1458: Cl/F(0 - 144 hours after dosing)
- Pharmacokinetic parameter of DWJ1458: AUCinf(0 - 144 hours after dosing)
- Pharmacokinetic parameter of DWJ1458: Tmax(0 - 144 hours after dosing)
- Pharmacokinetic parameter of DWJ1458: t1/2(0 - 144 hours after dosing)
- Pharmacokinetic parameter of DWJ1458: Vd/F(0 - 144 hours after dosing)