Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects
A Randomized, Open-label Study to Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects
1 other identifier
interventional
32
1 country
1
Brief Summary
The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2021
Shorter than P25 for phase_1
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
Study Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2021
CompletedFirst Submitted
Initial submission to the registry
November 15, 2021
CompletedFirst Posted
Study publicly available on registry
December 8, 2021
CompletedDecember 8, 2021
November 1, 2021
25 days
November 15, 2021
November 25, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
(part 2) AUC last of DWP14012
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(part 2) Cmax of DWP14012
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
Secondary Outcomes (7)
(Part 2) AUC inf of DWP14012
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(Part 2) Tmax of DWP14012
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(Part 2) t1/2 of DWP14012
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(part 1-period 1) AUC last of DWP14012
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours
(part 1-period 1) Cmax of DWP14012
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours
- +2 more secondary outcomes
Study Arms (2)
Part1
ACTIVE COMPARATORDWP14012 Tablet A : single/multiple dose, 1 group, 2 period study
Part2
ACTIVE COMPARATORDWP14012 Tablet A 4T vs DWP14012 Tablet B 1T
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adults \>=19years and \<=45 years of age
- BMI \>=17.5 kg/m2 and \<30.5kg/m2, and body weight \>= 55kg for male and \>= 45kg for femlae
- subjects with no abnormal symptoms or findings based on physical examinations
- subjects determined eligible based on the results of lab tests
- subjects who agree to participate
You may not qualify if:
- Subjects with medical history that can not be participated
- Subjects with results of lab tests performed at screening which meet any of the following :
- ALT or AST \> 1.5 times the upper limit of normal
- Diagnosis of Helicobacter pylori (H. pylori) positive result
- subject who is allergic to IP
- subject with history of serious alcohol or drug abuse within 1 year prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bundang CHA Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2021
First Posted
December 8, 2021
Study Start
October 1, 2021
Primary Completion
October 26, 2021
Study Completion
October 26, 2021
Last Updated
December 8, 2021
Record last verified: 2021-11