Drug-Drug Interaction Study Between CJ-12420 and Clarithromycin in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02052336
- Lead Sponsor
- HK inno.N Corporation
- Brief Summary
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
- Detailed Description
An open-label, randomized, 6-sequence, 3-period, 3-treatment crossover design
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CJ-12420 200 mg + Clarithromycin 500mg CJ-12420 200mg CJ-12420 200mg QD for 5 days + Clarithromycin 500mg BID for 5 days CJ-12420 200mg Clarithromycin 500mg CJ-12420 200mg QD for 5 days CJ-12420 200 mg + Clarithromycin 500mg Clarithromycin 500mg CJ-12420 200mg QD for 5 days + Clarithromycin 500mg BID for 5 days CJ-12420 200mg CJ-12420 200mg + Clarithromycin 500mg CJ-12420 200mg QD for 5 days Clarithromycin 500mg CJ-12420 200mg + Clarithromycin 500mg Clarithromycin 500mg BID for 5 days Clarithromycin 500mg CJ-12420 200mg Clarithromycin 500mg BID for 5 days
- Primary Outcome Measures
Name Time Method The effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin Blood sampling during 12 or 24hrs after administration Cmax, Cmin, Tmax, AUC(tau), CL/F, T1/2
- Secondary Outcome Measures
Name Time Method The safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects 6 days after last visit Safety and tolerability parameters will include laboratory (haematology, clinical chemistry, urinalysis, 12-lead ECG) values at Screening, Day-1 and Day 6 at each period and Follow-up.
Trial Locations
- Locations (1)
Inje university college of medicine Busan Paik Hospital
🇰🇷Busan, Korea, Republic of