Healthy
Conditions
Keywords
Drug-Drug interaction, Pharmacokinetics
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
Interventions
DRUGCJ-12420 200mg + Clarithromycin 500mg
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
DRUGCJ-12420 200mg
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed