A Study to Compare the Pharmacokinetic Characteristics of CJ-12420

Erosive Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995239
• Other study ID #: CJ_APA_106
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2016
• Last updated: December 13, 2016
• Start date: April 2015
• Est. completion date: April 2015

Study information

• Verified date: December 2016
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis

Intervention

Drug:
• CJ-12420 formulation 2
CJ-12420 formulation 2
• CJ-12420 formulation 1
CJ-12420 formulation 1

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Chonju

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the AUClast		Up to 48 hours	No
Secondary	Assessment of the AUCinf		Up to 48 hours	No
Secondary	Tmax		Up to 48 hours	No
Secondary	t1/2		Up to 48 hours	No
Secondary	Vd/F		Up to 48 hours	No