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

Phase 1

Completed

• Conditions: Phase 1 Study, Healthy Volunteers
• Interventions: Drug: DWP14012 Tablet A; Drug: DWP14012 Tablet B

• Registration Number: NCT05149274
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2021-10-26
• Study Completion: 2021-10-26
• Status Verified: 2021-11
• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-25
• Last Update Submitted: 2021-11-25
• Study First Posted: 2021-12-08
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part1	DWP14012 Tablet A	DWP14012 Tablet A : single/multiple dose, 1 group, 2 period study
Part2	DWP14012 Tablet A	DWP14012 Tablet A 4T vs DWP14012 Tablet B 1T
Part2	DWP14012 Tablet B	DWP14012 Tablet A 4T vs DWP14012 Tablet B 1T

Primary Outcome Measures

Name	Time	Method
(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

Name	Time	Method
(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 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 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 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
(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

Trial Locations

Locations (1)

Bundang CHA Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of