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OpenTrials
Completed

NCT Number: NCT05149274

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.

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Key information

Conditions

Phase 1 Study, Healthy Volunteers

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bundang CHA Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DWP14012 Tablet A

Drug

DWP14012 10mg

DWP14012 Tablet B

Drug

DWP14012 40mg

Primary outcomes

  1. (part 2) AUC last of DWP14012

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing

  2. (part 2) Cmax of DWP14012

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing

Secondary outcomes

  1. (Part 2) AUC inf of DWP14012

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing

  2. (Part 2) Tmax of DWP14012

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing

  3. (Part 2) t1/2 of DWP14012

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing

  4. (part 1-period 1) AUC last of DWP14012

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours

  5. (part 1-period 1) Cmax of DWP14012

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours

  6. (part 1- period 2) AUC last of DWP14012

    Time frame: 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

  7. (part 1- period 2) Cmax of DWP14012

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2021
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.