Pharmacokinetics and Safety of DWP14012 Tablet A and Tablet B in Healthy Volunteers (III)

Phase 1

• Conditions: Healthy
• Interventions: Drug: DWP14012 tablet A; Drug: DWP14012 tablet B

• Registration Number: NCT04185805
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-04
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-06
• Study Start: 2019-12-14
• Primary Completion: 2020-02-28
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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 appendectomy 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2 (Tablet A - Tablet B)	DWP14012 tablet B	Period 1 : DWP14012 tablet A Period 2: DWP14012 tablet B
Sequence 1 (Tablet B - Tablet A)	DWP14012 tablet B	Period 1 : DWP14012 tablet B Period 2: DWP14012 tablet A
Sequence 2 (Tablet A - Tablet B)	DWP14012 tablet A	Period 1 : DWP14012 tablet A Period 2: DWP14012 tablet B
Sequence 1 (Tablet B - Tablet A)	DWP14012 tablet A	Period 1 : DWP14012 tablet B Period 2: DWP14012 tablet A

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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: Apparent 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

Trial Locations

Locations (1)

Bundang CHA Medical Center; 🇰🇷 Gyeonggi-do, Korea, Republic of