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CompletedNCT02995239Updated Dec 16, 2016

A Study to Compare the Pharmacokinetic Characteristics of CJ-12420

A Phase 1 interventional study of CJ-12420 formulation 2 and CJ-12420 formulation 1 in Erosive Esophagitis, sponsored by HK inno.N Corporation. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-16.

Sponsored by HK inno.N Corporation · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Erosive Esophagitis

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03

In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.

This study's enrollment of 12 is below the median of 66 across 215 interventional studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    CJ-12420 formulation 1

    CJ-12420 formulation 1

    Drug: CJ-12420 formulation 2

  • Active comparator
    CJ-12420 formulation 2

    CJ-12420 formulation 2

    Drug: CJ-12420 formulation 1

Interventions

  • DrugCJ-12420 formulation 2

    CJ-12420 formulation 2

  • DrugCJ-12420 formulation 1

    CJ-12420 formulation 1

06

What researchers measure

Primary outcomes

  1. Assessment of the AUClast

    Time frame: Up to 48 hours

Secondary outcomes

  1. Assessment of the AUCinf

    Time frame: Up to 48 hours

  2. Tmax

    Time frame: Up to 48 hours

  3. t1/2

    Time frame: Up to 48 hours

  4. Vd/F

    Time frame: Up to 48 hours

07

Study locations

1 site
  • Chonbuk National University Hospital
    Chonju, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02995239
Lead sponsor
HK inno.N Corporation
Responsible party
Sponsor
First posted
Dec 16, 2016
Start date
Apr 2015
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Dec 16, 2016

Study contacts

Min-Gul Kim, MD
principal investigator · Chonbuk university hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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