A Study to Compare the Pharmacokinetic Characteristics of CJ-12420

HK inno.N

Status and phase

Completed

Phase 1

Conditions

Erosive Esophagitis

Treatments

Drug: CJ-12420 formulation 1

Drug: CJ-12420 formulation 2

Study type

Interventional

Funder types

Industry

Identifiers

CJ_APA_106

Details and patient eligibility

About

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

Full description

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

Enrollment

12 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.