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

NCT ID: NCT04185805

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-14

Study Completion Date

2020-04-30

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence 1 (Tablet B - Tablet A)

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

Group Type EXPERIMENTAL

DWP14012 tablet A

Intervention Type DRUG

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

DWP14012 tablet B

Intervention Type DRUG

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

Sequence 2 (Tablet A - Tablet B)

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

Group Type EXPERIMENTAL

DWP14012 tablet A

Intervention Type DRUG

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

DWP14012 tablet B

Intervention Type DRUG

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

Interventions

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DWP14012 tablet A

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

Intervention Type DRUG

DWP14012 tablet B

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bundang CHA Medical Center

Gyeonggi-do, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Anhye Kim

Role: primary

Other Identifiers

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DW_DWP14012103

Identifier Type: -

Identifier Source: org_study_id