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

NCT04185805 | Unknown Phase 1

• 1 other identifier: DW_DWP14012103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Sequence 1 (Tablet B - Tablet A)

EXPERIMENTAL

Period 1 : DWP14012 tablet B Period 2: DWP14012 tablet A

Drug: DWP14012 tablet A; Drug: DWP14012 tablet B

Sequence 2 (Tablet A - Tablet B)

EXPERIMENTAL

Period 1 : DWP14012 tablet A Period 2: DWP14012 tablet B

Drug: DWP14012 tablet A; Drug: DWP14012 tablet B

Interventions

DWP14012 tablet A DRUG

Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A

Sequence 1 (Tablet B - Tablet A); Sequence 2 (Tablet A - Tablet B)

DWP14012 tablet B DRUG

Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B

Sequence 1 (Tablet B - Tablet A); Sequence 2 (Tablet A - Tablet B)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Bundang CHA Medical Center

Gyeonggi-do, South Korea

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 4, 2019
• Study Start: December 14, 2019
• Primary Completion: February 28, 2020
• Study Completion: April 30, 2020
• Last Updated: December 6, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)