An Exploratory Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Adult Volunteers
Overview
- Phase
- Phase 1
- Intervention
- DWC202003
- Conditions
- Healthy
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults.
Detailed Description
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adult volunteers aged 19 years old to under
- •BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg
- •Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.
- •Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).
- •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
- •Known history or presence of any clinically significant medical condition.
- •Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.
- •Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.
- •Refusal to abstain from alcohol, caffeine, or other xanthines, or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.
- •Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.
Arms & Interventions
Sequence A
7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.
Intervention: DWC202003
Sequence A
7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.
Intervention: DWJ1439
Sequence A
7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.
Intervention: DWJ1464
Sequence B
7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.
Intervention: DWJ1464
Sequence B
7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.
Intervention: DWC202003
Sequence B
7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.
Intervention: DWC202004
Sequence C
7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.
Intervention: DWJ1439
Sequence C
7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.
Intervention: DWC202003
Sequence C
7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.
Intervention: DWC202004
Sequence D
7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.
Intervention: DWJ1439
Sequence D
7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.
Intervention: DWJ1464
Sequence D
7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.
Intervention: DWC202004
Outcomes
Primary Outcomes
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t
Time Frame: 0 - 72 hours after dosing
Area under the plasma concentration-time curve from time 0 to time t
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax
Time Frame: 0 - 72 hours after dosing
Maximum plasma drug concentration
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax
Time Frame: 0 - 72 hours after dosing
Maximum plasma drug concentration
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t
Time Frame: 0 - 72 hours after dosing
Area under the plasma concentration-time curve from time 0 to time t
Secondary Outcomes
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F(0 - 72 hours after dosing)