Drug-Drug Interaction Study Between CJ-12420 and Clarithromycin in Healthy Male Subjects
This trial has been completed.
|Treatments||cj-12420 200mg + clarithromycin 500mg, cj-12420 200mg, clarithromycin 500mg|
|Sponsor||CJ HealthCare Corporation|
|Start date||October 2013|
|End date||January 2014|
|Trial size||24 participants|
|Trial identifier||NCT02052336, CJ_APA_103|
Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
Secondary Objective(s): To assess the safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects
|Endpoint classification||pharmacokinetics study|
|Intervention model||crossover assignment|
|Primary purpose||basic science|
The effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin
time frame: Blood sampling during 12 or 24hrs after administration
The safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects
time frame: 6 days after last visit
Male participants from 19 years up to 45 years old.
Inclusion Criteria: - Healthy male volunteers in the age between 19 and 45 years old - Body mass index(BMI) in the range of 19 to 28 kg/m2 - Understand the requirement of the study and voluntarily consent to paticipate in the study Exclusion Criteria: - History of clinically significant medical history or disease (hepatic, kidney, gastrointestinal,respiratory, musculoskeletal, endocrine,neuro-psychiatric, haemato-oncologic,urinary tract, cardiac arrhythmia and cardiovascular system) judged by investigator. - Clinically significant abnormal laboratory results within at least 28 days prior to the first day of drug administration. AST or ALT > 1.25 times of upper limit value Total bilirubin > 1.5 times of upper limit value estimated GFR :less than 80 mL/min - Clinically significant abnormal ECG results within at least 28 days prior to the first day of drug administration PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 500 msec - Clinically significant hypersensitivity reaction against investigational drug or other drugs - history of drug abuse or "positive" results from drug screening test. - Take medicine such as prescription medicine or herbal medicine, over-the-counter drug, vitamin supplements - Person who have intake history of food or drug which can affect drug absorption, drug distribution, drug metabolism, and drug excretion and bowel activity - Volunteer have a history of donation of whole blood donation, apheresis, transfusion - Volunteer a heavy drinker(30g/day), smoker(10 cigarettes/day), heavy caffeine consumer(400mg/day)
|Official title||An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between CJ-12420 and Clarithromycin in Healthy Male Subjects|
|Description||An open-label, randomized, 6-sequence, 3-period, 3-treatment crossover design|
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