Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects

NCT05574374 — Phase 1, Completed, 36 participants, Daewoong Pharmaceutical Co. LTD.

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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

RegistryNCT05574374
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, crossover, masking: none, treatment
Enrollment36 (Actual)
SponsorDaewoong Pharmaceutical Co. LTD. (Industry)
ConditionsDrug Drug Interaction
InterventionsDWP14012, DWC202202, DWC202203 (Drug)
Datesstart 2022-09-21, primary completion 2023-03-06, completion 2023-03-06, first posted 2022-10-10, last updated 2023-04-04
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Drug Drug Interaction All trials of DWP14012 All trials of DWC202202

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
Cohort 1ExperimentalDrug: DWP14012; Drug: DWC202202; Drug: DWC202203* Treatment A: DWC202202 1 tablet qd for 7days * Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days * Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
Cohort 2ExperimentalDrug: DWP14012; Drug: DWC202202; Drug: DWC202203* Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days * Treatment A: DWC202202 1 tablet qd for 7days * Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
Cohort 3ExperimentalDrug: DWP14012; Drug: DWC202202; Drug: DWC202203* Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days * Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days * Treatment A: DWC202202 1 tablet qd for 7days
  • DWP14012 (Drug): Potassium-competitive acid blocker
  • DWC202202 (Drug): Clopidogrel Bisulfate
  • DWC202203 (Drug): Proton pump inhibitor

+Outcome measures

Primary outcomes

  • Emax [up to 50 days]
  • AUEC0-24 [up to 50 days]

Secondary outcomes

  • DWC202202 Cmax,ss [up to 50 days]
  • DWC202202 active metabolite Cmax,ss [up to 50 days]
  • DWC202202 AUCtau,ss [up to 50 days]
  • DWC202202 active metabolite AUCtau,ss [up to 50 days]
  • DWC202202 AUCinf,ss [up to 50 days]
  • DWC202202 active metabolite AUCinf,ss [up to 50 days]
  • DWC202202 Tmax,ss [up to 50 days]
  • DWC202202 active metabolite Tmax,ss [up to 50 days]
  • DWC202202 t1/2,ss [up to 50 days]
  • DWC202202 active metabolite t1/2,ss [up to 50 days]
  • DWC202202 Cmin,ss [up to 50 days]
  • DWC202202 active metabolite Cmin,ss [up to 50 days]
  • DWC202202 Cavg,ss [up to 50 days]
  • DWC202202 active metabolite Cavg,ss [up to 50 days]
  • DWC202202 CLss/F [up to 50 days]
  • DWC202202 Vd,ss/F [up to 50 days]
  • DWC202202 PTF (peak to trough fluctuation) [up to 50 days]
  • DWC202202 active metabolite PTF (peak to trough fluctuation) [up to 50 days]
  • DWC202202 R [up to 50 days]
  • DWC202202 active metabolite MR [up to 50 days]

+Eligibility

Sex: All, ages: 19 Years to 50 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Seoul National University HospitalSeoulSouth Korea