Pharmacokinetics and Safety of DWP14012 Tablet A and Tablet B in Healthy Volunteers

A Randomized, Open-label, Single Dose Study to Evaluate the Safety and Pharmacokinetics of DWP14012 Tablet A and DWP14012 Tablet B in Healthy Volunteers

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: DWP14012 tablet A; Drug: DWP14012 tablet B

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Recruiting
      • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt: Area under the drug concentration-time curve from time 0 to tau (dosing interval)	each period	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
Cmax: Peak concentration of DWP14012	each period	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf: Area under the drug concentration-time curve from time 0 to infinity	each period	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
Tmax: Time of maximum concentration	each period	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
t1/2: Terminal elimination half-life	each period	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
Vd/F: Apparent volume of distribution	each period	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
CL/F: Apperent Clearance	each period	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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2019
• Primary Completion (ANTICIPATED): August 1, 2019
• Study Completion (ANTICIPATED): August 1, 2019

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (ACTUAL): July 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWP14012101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No