Drug-Drug Interaction Study Between CJ-12420 and Clarithromycin in Healthy Male Subjects
Information source: CJ HealthCare Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: CJ-12420 200mg + Clarithromycin 500mg (Drug); CJ-12420 200mg (Drug); Clarithromycin 500mg (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: CJ HealthCare Corporation
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: The effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin
Secondary outcome: 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
Eligibility
Minimum age: 19 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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)
Locations and Contacts
Inje university college of medicine Busan Paik Hospital, Busan, Korea, Republic of
Additional Information
Starting date: October 2013
Last updated: January 29, 2014
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