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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02995239
Other study ID # CJ_APA_106
Secondary ID
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


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
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