Pharmacokinetics and Safety of DWP14012 Tablet A and Tablet B in Healthy Volunteers (II)
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence 1 (Tablet B - Tablet A) Period 1 : DWP14012 tablet B Period 2: DWP14012 tablet A |
Drug: DWP14012 tablet A
Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A
Drug: DWP14012 tablet B
Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B
|
| Experimental: Sequence 2 (Tablet A - Tablet B) Period 1 : DWP14012 tablet A Period 2: DWP14012 tablet B |
Drug: DWP14012 tablet A
Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A
Drug: DWP14012 tablet B
Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chonbuk National University Hospital | Jeonju | Jeollabuk-do | Korea, Republic of | 54907 |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_DWP14012102