A Study to Compare the Pharmacokinetic Characteristics of... | NCT02995239

Studies
A Study to Compare the Pharmacokinetic Characteristics of CJ-12420

NCT02995239

Sponsor

HK inno.N Corporation

Status

Completed

Last Update Posted

Dec 16, 2016Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Erosive Esophagitis

Interventions

CJ-12420 formulation 2
CJ-12420 formulation 1

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Jul 15, 2016

First Submission Date that Met QC Criteria

Dec 13, 2016

First Posted Date

Dec 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2016

Last Update Posted Date

Dec 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CJ-12420 formulation 1	Active Comparator	CJ-12420 formulation 1	Drug: CJ-12420 formulation 2
CJ-12420 formulation 2	Active Comparator	CJ-12420 formulation 2	Drug: CJ-12420 formulation 1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CJ-12420 formulation 2	Drug	CJ-12420 formulation 2	CJ-12420 formulation 1

Measure	Description	Time Frame
Assessment of the AUClast		Up to 48 hours

Measure	Description	Time Frame
Assessment of the AUCinf		Up to 48 hours
Tmax		Up to 48 hours
t1/2

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Min-Gul Kim, MD	Chonbuk university hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chonbuk National University Hospital		Jeonju			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided