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

The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Phase 1 Study, Healthy Volunteers
• Intervention / Treatment: Drug: DWP14012 Tablet A; Drug: DWP14012 Tablet B

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • Bundang CHA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(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

Outcome Measure	Time Frame
(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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): October 26, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWP14012107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No