Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers
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
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Aug 2020
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedStudy Start
First participant enrolled
August 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedJuly 29, 2020
July 1, 2020
25 days
June 22, 2020
July 27, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t
Area under the plasma concentration-time curve from time 0 to time t
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax
Maximum plasma drug concentration
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t
Area under the plasma concentration-time curve from time 0 to time t
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax
Maximum plasma drug concentration
0 - 72 hours after dosing
Secondary Outcomes (10)
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax
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: , Cl/F
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F
0 - 72 hours after dosing
- +5 more secondary outcomes
Study Arms (4)
Sequence A
OTHER7 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.
Sequence B
OTHER7 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.
Sequence C
OTHER7 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.
Sequence D
OTHER7 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyung Hee University Medical Hospital
Seoul, South Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2020
First Posted
July 20, 2020
Study Start
August 6, 2020
Primary Completion
August 31, 2020
Study Completion
September 1, 2020
Last Updated
July 29, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share