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Status unknownNCT05812404Updated Apr 13, 2023

Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects

A Phase 1 interventional study of DWP14012 and DWC202201 in Drug Drug Interaction, sponsored by Daewoong Pharmaceutical Co. LTD.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-13.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study summary

A randomized, open-label, three-period, three-sequence, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacokinetics of DWC202201 after co-administration of DWP14012 and DWC202201 in healthy subjects

02

Conditions studied

  • Drug Drug Interaction
03

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Subjects with a disease or a history related to hepatobiliary system, kidney(severe kidney disorder ect.), nervous system, respiratory system, digestive system, endocrine system, hematology system, circulatory system(Heart failure, Torsades de pointes ect.), unrinary system, psychiatry ect.
  • Subjects with digestive disease(gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal disease, Crohn's disease) or history of surgery(except appendectomy, hernia surgery) which can affect on saftey and pharmacodynamics
  • Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc.
  • Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
  • Subjects with history of inherited muscle disorders
  • 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
  • Subjects who are unable to refrain from smoking(>10pieces/day) from 3 days prior to the first scheduled dose until last discharge from hospital
  • Subjects with alchoholic disorders or subjects who are unable to refrain from drinking(>21units/week) from 3 days prior to the first scheduled dose until last discharge from hospital
  • Subjects who are unable to refrain from caffein(>5units/day) from 3 days prior to the first scheduled dose until last discharge from hospital
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    * Treatment A: DWC202201 40 mg qd for 7 days * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days * Treatment C: DWP14012 40 mg qd for 14 days

    Drug: DWP14012 · Drug: DWC202201

  • Experimental
    Cohort 2

    * Treatment C: DWP14012 40 mg qd for 14 days * Treatment A: DWC202201 40 mg qd for 7 days * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days

    Drug: DWP14012 · Drug: DWC202201

  • Experimental
    Cohort 3

    * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days * Treatment C: DWP14012 40 mg qd for 14 days * Treatment A: DWC202201 40 mg qd for 7 days

    Drug: DWP14012 · Drug: DWC202201

Interventions

  • DrugDWP14012

    Potassium-competitive acid blocker

  • DrugDWC202201

    Atorvastatin Calcium Trihydrate

06

What researchers measure

Primary outcomes

  1. Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  2. Atorvastatin Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

Secondary outcomes

  1. Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  2. Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  3. Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  4. Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  5. Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  6. Atorvastatin active metabolite Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  7. Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  8. Atorvastatin active metabolite An estimate of the total body clearance at steady state (CL ss/F) after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  9. Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  10. Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  11. Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing

    Time frame: [Time Frame: up to 64 days]

  12. Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing

    Time frame: [Time Frame: up to 64 days]

  13. Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing

    Time frame: [Time Frame: up to 64 days]

  14. Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing

    Time frame: [Time Frame: up to 64 days]

  15. Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing

    Time frame: [Time Frame: up to 64 days]

  16. Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing

    Time frame: [Time Frame: up to 64 days]

  17. Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing

    Time frame: [Time Frame: up to 64 days]

  18. Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  19. Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after DWP14012 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  20. Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity at steady state (AUCinf,ss) after DWP14012 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  21. Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  22. Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  23. Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  24. Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  25. Fexuprazan Accumulation ratio after DWP14012 multiple dosing

    Time frame: [Time Frame: up to 64 days]

  26. Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing

    Time frame: [Time Frame: up to 64 days]

  27. Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after single dosing

    Time frame: [Time Frame: up to 64 days]

  28. Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing

    Time frame: [Time Frame: up to 64 days]

  29. Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing

    Time frame: [Time Frame: up to 64 days]

  30. Fexuprazan active metabolite metabolic ratio after single dosing

    Time frame: [Time Frame: up to 64 days]

  31. Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing

    Time frame: [Time Frame: up to 64 days]

  32. Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio

    Time frame: [Time Frame: up to 64 days]

  33. Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after multiple dosing

    Time frame: [Time Frame: up to 64 days]

  34. Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity at steady state (AUCinf,ss) after multiple dosing

    Time frame: [Time Frame: up to 64 days]

  35. Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing

    Time frame: [Time Frame: up to 64 days]

  36. Fexuprazan active metabolite metabolic ratio after multiple dosing

    Time frame: [Time Frame: up to 64 days]

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05812404
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Apr 13, 2023
Start date
Oct 26, 2022
Primary completion
Mar 28, 2023
Completion
Jun 16, 2023 (estimated)
Last update
Apr 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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