Drug Drug Interaction
Conditions
Brief 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
Interventions
DRUGDWP14012
Potassium-competitive acid blocker
DRUGDWC202201
Atorvastatin Calcium Trihydrate
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
Secondary
| Measure | Time frame |
|---|---|
| Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin active metabolite Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin active metabolite An estimate of the total body clearance at steady state (CL ss/F) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing | [Time Frame: up to 64 days] |
| Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Accumulation ratio after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after single dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite metabolic ratio after single dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio | [Time Frame: up to 64 days] |
| 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: up to 64 days] |
| Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity at steady state (AUCinf,ss) after multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan active metabolite metabolic ratio after multiple dosing | [Time Frame: up to 64 days] |
| Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity at steady state (AUCinf,ss) after DWP14012 multiple dosing | [Time Frame: up to 64 days] |
| Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing | [Time Frame: up to 64 days] |
Countries
South Korea
Outcome results
None listed