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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Phase 1 Study, Healthy Volunteers

Treatments: Drug: DWP14012 Tablet B; Drug: DWP14012 Tablet A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05149274

DW_DWP14012107

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Part1

Active Comparator group

Description:

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

Treatment:

Drug: DWP14012 Tablet A

Part2

Active Comparator group

Description:

DWP14012 Tablet A 4T vs DWP14012 Tablet B 1T

Treatment:

Drug: DWP14012 Tablet B

Drug: DWP14012 Tablet A