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Completed

NCT Number: NCT02995239

A Study to Compare the Pharmacokinetic Characteristics of CJ-12420

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

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Key information

Conditions

Erosive Esophagitis

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Jeonju, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CJ-12420 formulation 2

Drug

CJ-12420 formulation 2

CJ-12420 formulation 1

Drug

CJ-12420 formulation 1

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

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of CJ-12420 in Healthy Male Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 16, 2016
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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