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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

Page last updated: August 23, 2015

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