Back to resultsA Study to Compare the Pharmacokinetic Characteristics of CJ-12420
Primary Purpose
Erosive Esophagitis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CJ-12420 formulation 2
CJ-12420 formulation 1
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Esophagitis
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.
Sites / Locations
- Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CJ-12420 formulation 1
CJ-12420 formulation 2
Arm Description
CJ-12420 formulation 1
CJ-12420 formulation 2
Outcomes
Primary Outcome Measures
Assessment of the AUClast
Secondary Outcome Measures
Assessment of the AUCinf
Tmax
t1/2
Vd/F
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02995239
Brief Title
A Study to Compare the Pharmacokinetic Characteristics of CJ-12420
Official Title
A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of CJ-12420 in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CJ-12420 formulation 1
Arm Type
Active Comparator
Arm Description
CJ-12420 formulation 1
Arm Title
CJ-12420 formulation 2
Arm Type
Active Comparator
Arm Description
CJ-12420 formulation 2
Intervention Type
Drug
Intervention Name(s)
CJ-12420 formulation 2
Intervention Description
CJ-12420 formulation 2
Intervention Type
Drug
Intervention Name(s)
CJ-12420 formulation 1
Intervention Description
CJ-12420 formulation 1
Primary Outcome Measure Information:
Title
Assessment of the AUClast
Time Frame
Up to 48 hours
Secondary Outcome Measure Information:
Title
Assessment of the AUCinf
Time Frame
Up to 48 hours
Title
Tmax
Time Frame
Up to 48 hours
Title
t1/2
Time Frame
Up to 48 hours
Title
Vd/F
Time Frame
Up to 48 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Gul Kim, MD
Organizational Affiliation
Chonbuk university hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Chonju
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Compare the Pharmacokinetic Characteristics of CJ-12420
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