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Completed

NCT Number: NCT05304845

Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

This is a randomized, open-label study to evaluate the safety/tolerability and PK/PD drug-drug interactions between DWP14012 and aspirin when administered in combination.

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Key information

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults aged ≥ 19 and ≤ 50 years at screening
  • Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening

※ BMI (kg/m2) = body weight (kg)/[height (m)]2

  • Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
  • Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
  • For women, negative urine pregnancy test (hCG) at the screening visit

Exclusion criteria

  • Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, salicylic acid, or other drugs (non-steroidal anti-inflammatory drug [NSAIDs], antibiotics, etc.)
  • Women who are or may be pregnant, or are breast-feeding
  • Subjects with a history related to blood clotting disorder or bleeding
  • Subjects with a medical diagnosis of functional constipation
  • Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen
  • Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP
  • Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose
  • Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital
  • Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration, and disagreed to refrain from donating sperms during this period
  • Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.

Treatment and study plan

DWP14012

Drug

Potassium-competitive acid blocker

Aspirin

Drug

acetylsalicylic acid

Primary outcomes

  1. Cmax of aspirin

    Time frame: Up to 21 days

  2. Cmax,ss of DWP14012

    Time frame: Up to 13 days

  3. Emax

    Time frame: Up to 21 days

  4. AUClast of aspirin

    Time frame: Up to 21 days

  5. AUCτ,ss of DWP14012

    Time frame: Up to 13 days

  6. time to Emax

    Time frame: Up to 21 days

  7. AUEC

    Time frame: Up to 21 days

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Randomized, Open-label Study to Evaluate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Apr 5, 2023

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.

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