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

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: DWP14012 tablet A; Drug: DWP14012 tablet B

Study type: Interventional

Funder types: Industry

Identifiers

NCT04167267

DW_DWP14012102

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Sequence 1 (Tablet B - Tablet A)

Experimental group

Description:

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

Treatment:

Drug: DWP14012 tablet B

Drug: DWP14012 tablet A

Sequence 2 (Tablet A - Tablet B)

Experimental group

Description:

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

Treatment:

Drug: DWP14012 tablet B

Drug: DWP14012 tablet A