Healthy
Conditions
Brief summary
This is a randomized, open-label, single dose study to evaluate the safety and pharmacokinetics of DWP14012 tablet A and DWP14012 tablet B in healthy volunteers
Interventions
Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A
Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult aged between 19 and 45 at screening * Those whose weight is 55 kg and more and BMI is between 17.5 and 30.5 kg/m2 * Subjects who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Exclusion criteria
* Subjects who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history * Subjects who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple ppendectomy and herniotomy) * Subjects who showed positive result for Helicobacter pylori test * Subjects with serum AST (SGOT) or ALT (SGPT) level \>1.5 times the upper limit of the normal range at the time of the screening examination * Subjects with a history of drug abuse or a positive urine screening for drug abuse * Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration * Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt: Area under the drug concentration-time curve from time 0 to tau (dosing interval) | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | each period |
| Cmax: Peak concentration of DWP14012 | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | each period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2: Terminal elimination half-life | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | each period |
| AUCinf: Area under the drug concentration-time curve from time 0 to infinity | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | each period |
| Vd/F: Apparent volume of distribution | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | each period |
| CL/F: Apperent Clearance | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | each period |
| Tmax: Time of maximum concentration | 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour | each period |
Countries
South Korea
Outcome results
None listed