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OpenTrials
Completed

NCT Number: NCT05574374

Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects

A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects

Completed

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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.

Exclusion criteria

  • Subjects with a history related to blood clotting disorder or bleeding
  • Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc.
  • 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 with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
  • 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
  • Subjects who are smoking

Treatment and study plan

DWP14012

Drug

Potassium-competitive acid blocker

DWC202202

Drug

Clopidogrel Bisulfate

DWC202203

Drug

Proton pump inhibitor

Primary outcomes

  1. Emax

    Time frame: up to 50 days

  2. AUEC0-24

    Time frame: up to 50 days

Secondary outcomes

  1. DWC202202 Cmax,ss

    Time frame: up to 50 days

  2. DWC202202 active metabolite Cmax,ss

    Time frame: up to 50 days

  3. DWC202202 AUCtau,ss

    Time frame: up to 50 days

  4. DWC202202 active metabolite AUCtau,ss

    Time frame: up to 50 days

  5. DWC202202 AUCinf,ss

    Time frame: up to 50 days

  6. DWC202202 active metabolite AUCinf,ss

    Time frame: up to 50 days

  7. DWC202202 Tmax,ss

    Time frame: up to 50 days

  8. DWC202202 active metabolite Tmax,ss

    Time frame: up to 50 days

  9. DWC202202 t1/2,ss

    Time frame: up to 50 days

  10. DWC202202 active metabolite t1/2,ss

    Time frame: up to 50 days

  11. DWC202202 Cmin,ss

    Time frame: up to 50 days

  12. DWC202202 active metabolite Cmin,ss

    Time frame: up to 50 days

  13. DWC202202 Cavg,ss

    Time frame: up to 50 days

  14. DWC202202 active metabolite Cavg,ss

    Time frame: up to 50 days

  15. DWC202202 CLss/F

    Time frame: up to 50 days

  16. DWC202202 Vd,ss/F

    Time frame: up to 50 days

  17. DWC202202 PTF (peak to trough fluctuation)

    Time frame: up to 50 days

  18. DWC202202 active metabolite PTF (peak to trough fluctuation)

    Time frame: up to 50 days

  19. DWC202202 R

    Time frame: up to 50 days

  20. DWC202202 active metabolite MR

    Time frame: up to 50 days

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Randomized, Open-label, Three-sequence, Three-period, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacodynamics of DWC202202 in Combination With DWP14012 in Healthy Subjects

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2022
Registry last updated
Apr 4, 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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