Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Drug: DWJ1439
300mg single dose
Drug: DWJ1464
300mg single dose
Drug: DWC202003
300mg single dose
|
| Other: 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. |
Drug: DWJ1464
300mg single dose
Drug: DWC202003
300mg single dose
Drug: DWC202004
300mg single dose
|
| Other: 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. |
Drug: DWJ1439
300mg single dose
Drug: DWC202003
300mg single dose
Drug: DWC202004
300mg single dose
|
| Other: 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. |
Drug: DWJ1439
300mg single dose
Drug: DWJ1464
300mg single dose
Drug: DWC202004
300mg single dose
|
Outcome Measures
Primary Outcome Measures
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t [0 - 72 hours after dosing]
Area under the plasma concentration-time curve from time 0 to time t
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax [0 - 72 hours after dosing]
Maximum plasma drug concentration
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t [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 [0 - 72 hours after dosing]
Maximum plasma drug concentration
Secondary Outcome Measures
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf [0 - 72 hours after dosing]
Area under the plasma concentration-time curve from drug administration to drug elimination
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax [0 - 72 hours after dosing]
Time to reach maximum plasma concentration following drug administration
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2 [0 - 72 hours after dosing]
Elimination half-life
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F [0 - 72 hours after dosing]
Apparent total clearance of drug from plasma after oral administration
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F [0 - 72 hours after dosing]
Apparent volume of distribution after oral administration
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf [0 - 72 hours after dosing]
Area under the plasma concentration-time curve from drug administration to drug elimination
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax [0 - 72 hours after dosing]
Time to reach maximum plasma concentration following drug administration
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2 [0 - 72 hours after dosing]
Elimination half-life
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F [0 - 72 hours after dosing]
Apparent total clearance of drug from plasma after oral administration
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F [0 - 72 hours after dosing]
Apparent volume of distribution after oral administration
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy adult volunteers aged 19 years old to under 55.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kyung Hee University Medical Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_DWJ1464101