Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Completed

CT.gov ID

NCT05149274

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Phase 1 Study, Healthy Volunteers	Drug: DWP14012 Tablet A Drug: DWP14012 Tablet B	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2021

Actual Primary Completion Date :

Oct 26, 2021

Actual Study Completion Date :

Oct 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Part1 DWP14012 Tablet A : single/multiple dose, 1 group, 2 period study	Drug: DWP14012 Tablet A DWP14012 10mg
Active Comparator: Part2 DWP14012 Tablet A 4T vs DWP14012 Tablet B 1T	Drug: DWP14012 Tablet A DWP14012 10mg Drug: DWP14012 Tablet B DWP14012 40mg

Arm

Intervention/Treatment

Active Comparator: Part1

DWP14012 Tablet A : single/multiple dose, 1 group, 2 period study

Drug: DWP14012 Tablet A

DWP14012 10mg

Active Comparator: Part2

DWP14012 Tablet A 4T vs DWP14012 Tablet B 1T

Drug: DWP14012 Tablet A

DWP14012 10mg

Drug: DWP14012 Tablet B

DWP14012 40mg

Outcome Measures

Primary Outcome Measures

(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 Outcome Measures

(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]
(part 1- period 2) AUC last of DWP14012 [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]
(part 1- period 2) Cmax of DWP14012 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bundang CHA Medical Center	Seongnam-si	Gyeonggi-do	Korea, Republic of

Sponsors and Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT05149274

Other Study ID Numbers:

DW_DWP14012107

First Posted:

Dec 8, 2021

Last Update Posted:

Dec 8, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 8, 2021