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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185805
• Other study ID #: DW_DWP14012103
• Status: Recruiting
• Phase: Phase 1
• Start date: December 14, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: December 2019
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: April 30, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Bundang CHA Medical Center	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	CL/F: Apparent 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
Secondary	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