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A Study to Compare the Pharmacokinetic Characteristics of CJ-12420

NCT ID: NCT02995239

Last Updated: 2016-12-16

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-04-30

Brief Summary

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To compare the pharmacokinetics after administration of different formulation of CJ-12420

Detailed Description

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The purpose of this study is to compare the pharmacokinetics after a single dose administration of CJ-12420 formulation 1 and formulation 2.

Conditions

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Erosive Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CJ-12420 formulation 1

CJ-12420 formulation 1

Group Type ACTIVE_COMPARATOR

CJ-12420 formulation 2

Intervention Type DRUG

CJ-12420 formulation 2

CJ-12420 formulation 2

CJ-12420 formulation 2

Group Type ACTIVE_COMPARATOR

CJ-12420 formulation 1

Intervention Type DRUG

CJ-12420 formulation 1

Interventions

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CJ-12420 formulation 2

CJ-12420 formulation 2

Intervention Type DRUG

CJ-12420 formulation 1

CJ-12420 formulation 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male aged 19 to 45 years at the screening
* Subject who is over 50kg with BMI between 19 kg/m2 to 28 kg/m2 (inclusive)
* Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.

Exclusion Criteria

* Subject who fall under the criteria below in laboratory test.

* AST, ALT, ALP, GGT, total bilirubin, BUN, creatinine \> UNL x 1.5
* Subject who with low blood pressure with clinical significance at screening test.

* (systolic blood pressure is less than 90 mmHg or over 140 mmHg, and diastolic blood pressure is less than 50 mmHg or over 90 mmHg)
* Subject who has a medical history of symptomatic GERD, erosive esophagitis or duodenal ulcer, gastric ulcer, barrett's esophagus or zollinger-ellison syndrome.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min-Gul Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk university hospital

Locations

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Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CJ_APA_106

Identifier Type: -

Identifier Source: org_study_id