A Study to Compare the Pharmacokinetic Characteristics of CJ-12420
Phase 1
Completed
- Conditions
- Erosive Esophagitis
- Interventions
- Registration Number
- NCT02995239
- Lead Sponsor
- HK inno.N Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CJ-12420 formulation 2 CJ-12420 formulation 1 CJ-12420 formulation 2 CJ-12420 formulation 1 CJ-12420 formulation 2 CJ-12420 formulation 1
- Primary Outcome Measures
Name Time Method Assessment of the AUClast Up to 48 hours
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Chonbuk National University Hospital
🇰🇷Chonju, Korea, Republic of