A Study to Compare the Pharmacokinetic Characteristics of CJ-12420

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

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

Study Overview

• Status: Completed
• Conditions: Erosive Esophagitis
• Intervention / Treatment: Drug: CJ-12420 formulation 2; Drug: CJ-12420 formulation 1

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chonju, Korea, Republic of
    • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CJ-12420 formulation 1	Drug: CJ-12420 formulation 2; CJ-12420 formulation 2
Active Comparator: CJ-12420 formulation 2	Drug: CJ-12420 formulation 1; CJ-12420 formulation 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the AUClast	Up to 48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Min-Gul Kim, MD, Chonbuk university hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Diseases; Esophagitis
• Other Study ID Numbers: CJ_APA_106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No