Clinical trial NCT05149274: Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Phase 1 Study, Healthy Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-12-08
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: (part 2) AUC last of DWP14012
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
measure: (part 2) Cmax of DWP14012
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
Secondary outcomes:
measure: (Part 2) AUC inf of DWP14012
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
measure: (Part 2) Tmax of DWP14012
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
measure: (Part 2) t1/2 of DWP14012
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
measure: (part 1-period 1) AUC last of DWP14012
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours
measure: (part 1-period 1) Cmax of DWP14012
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours
measure: (part 1- period 2) AUC last of DWP14012
timeFrame: 0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8
measure: (part 1- period 2) Cmax of DWP14012
timeFrame: 0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang CHA Medical Center
state: Gyeonggi-do
Study officials:
References: