NCT02995239

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

Same day

First QC Date

July 15, 2016

Last Update Submit

December 13, 2016

Conditions

Erosive Esophagitis

Outcome Measures

Primary Outcomes (1)

  • Assessment of the AUClast

    Up to 48 hours

Secondary Outcomes (4)

  • Assessment of the AUCinf

    Up to 48 hours

  • Tmax

    Up to 48 hours

  • t1/2

    Up to 48 hours

  • Vd/F

    Up to 48 hours

Study Arms (2)

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

CJ-12420 formulation 2DRUG

CJ-12420 formulation 2

CJ-12420 formulation 1
CJ-12420 formulation 1DRUG

CJ-12420 formulation 1

CJ-12420 formulation 2

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

Study Officials

  • Min-Gul Kim, MD

    Chonbuk university hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

December 16, 2016

Study Start

April 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations

KR(1)