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Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects

NCT ID: NCT03487562

Last Updated: 2019-06-26

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-08

Study Completion Date

2019-01-11

Brief Summary

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This is a randomized, open-label, multiple dose, two-part phase I clinical trial to compare the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after administrations of DWP14012 alone and combinations of DWP14012, Clarithromycin and Amoxicillin in healthy male subjects

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence 1

Part I: A-B-D-C A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid

Group Type EXPERIMENTAL

DWP14012 Amg

Intervention Type DRUG

DWP14012 Amg

Clarithromycin

Intervention Type DRUG

Clarithromycin 500 mg

Amoxicillin

Intervention Type DRUG

Amoxicillin 1 g

Sequence 2

Part I: B-C-A-D A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid

Group Type EXPERIMENTAL

DWP14012 Amg

Intervention Type DRUG

DWP14012 Amg

Clarithromycin

Intervention Type DRUG

Clarithromycin 500 mg

Amoxicillin

Intervention Type DRUG

Amoxicillin 1 g

Sequence 3

Part I: C-D-B-A A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid

Group Type EXPERIMENTAL

DWP14012 Amg

Intervention Type DRUG

DWP14012 Amg

Clarithromycin

Intervention Type DRUG

Clarithromycin 500 mg

Amoxicillin

Intervention Type DRUG

Amoxicillin 1 g

Sequence 4

Part I: D-A-C-B A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid

Group Type EXPERIMENTAL

DWP14012 Amg

Intervention Type DRUG

DWP14012 Amg

Clarithromycin

Intervention Type DRUG

Clarithromycin 500 mg

Amoxicillin

Intervention Type DRUG

Amoxicillin 1 g

A

Part II: (DWP14012 B mg + Clarithromycin 500 mg + Amoxicillin 1g) bid

Group Type EXPERIMENTAL

DWP14012 Bmg

Intervention Type DRUG

DWP14012 Bmg

Clarithromycin

Intervention Type DRUG

Clarithromycin 500 mg

Amoxicillin

Intervention Type DRUG

Amoxicillin 1 g

B

Part II: (DWP14012 A mg + Clarithromycin 500 mg + Amoxicillin 1g) bid

Group Type EXPERIMENTAL

DWP14012 Amg

Intervention Type DRUG

DWP14012 Amg

Clarithromycin

Intervention Type DRUG

Clarithromycin 500 mg

Amoxicillin

Intervention Type DRUG

Amoxicillin 1 g

C

Part II: (Lansoprazole 30 mg + Clarithromycin 500 mg + Amoxicillin 1g) bid

Group Type EXPERIMENTAL

Clarithromycin

Intervention Type DRUG

Clarithromycin 500 mg

Amoxicillin

Intervention Type DRUG

Amoxicillin 1 g

Lansoprazole

Intervention Type DRUG

Lansoprazole 30 mg

Interventions

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DWP14012 Amg

DWP14012 Amg

Intervention Type DRUG

DWP14012 Bmg

DWP14012 Bmg

Intervention Type DRUG

Clarithromycin

Clarithromycin 500 mg

Intervention Type DRUG

Amoxicillin

Amoxicillin 1 g

Intervention Type DRUG

Lansoprazole

Lansoprazole 30 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males aged between 19 and 50 at screening
* Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
* Part I: Those who have been helicobacter pylori negative at screening Part II: Those who have been helicobacter pylori positive at screening
* Those 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

* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* Those 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)
* Those whose plasma AST (SGOT) and ALT (SGPT) exceed to the upper limit of the normal range
* Those who have anatomical disability in insertion and maintenance of pH meter catheter
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

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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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWP14012003

Identifier Type: -

Identifier Source: org_study_id

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