Status:
COMPLETED
Food-Effect on PK and PD of Single Oral Dose of CJ-12420 in Healthy Male Subjects
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
* Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of CJ-12420 in healthy male subjects. * Secondary * To explore food effect on the pharmacodynamics (PD) of sing...
Eligibility Criteria
Inclusion
- Male volunteers in the age between 20 and 45 years old(inclusive)
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg (inclusive)
- Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate)
- 90 mmHg ≤ systolic blood pressure ≤ 140 mmHg
- 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg
- 45 beats per minute ≤ pulse rate ≤ 95 beats per minute
- Understand the requirements of the study and voluntarily consent to participate in the study
Exclusion
- Subjects will be excluded from the study if there is evidence of any of the following criteria: Last three criteria will be applied ONLY to PD/PK group.
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary,immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
- History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
- History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori
- The following criteria will be applied ONLY to PD/PK group
- H.pylori positive, as determined by the urea breath test
- Urine cotinine test positive
- Subject who were unable to be applicable for pH meter catheter
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01830309
Start Date
January 1 2013
End Date
February 1 2013
Last Update
April 12 2013
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea