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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05149274
Enrollment
32
Registered
2021-12-08
Start date
2021-10-01
Completion date
2021-10-26
Last updated
2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phase 1 Study, Healthy Volunteers

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.

Interventions

DRUGDWP14012 Tablet A

DWP14012 10mg

DRUGDWP14012 Tablet B

DWP14012 40mg

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frame
(part 2) AUC last of DWP140120 (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 DWP140120 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing

Secondary

MeasureTime frame
(Part 2) t1/2 of DWP140120 (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 DWP140120 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours
(Part 2) Tmax of DWP140120 (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) AUC last of DWP140120 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 DWP140120 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 1) Cmax of DWP140120 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours
(Part 2) AUC inf of DWP140120 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026