Effect on ECG of combination of moxifloxacin and voriconazole
Phase 4
- Conditions
- Health Condition 1: null- Renal failure patients whose creatinine clearance is 10-50 ml/min
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
Healthy volunteers who gives consent to participate in the study
AND
Renal failure patients whose creatinine clearance is 10-50 ml/min
Exclusion Criteria
Baseline QTC interval >450millisec on 3 repeated occasions
Use of concomitant medication that prolong QT interval
Use of any drug that inhibit or induce CYP450 enzymes and/or P-gp within 30 days prior to screening
family history of congenital long QT syndrome (LQTS) or sudden death
known allergic or contraindication to voriconazole or moxifloxacin
Pregnant or lactating mother
HIV positive patient
HBsAg positive individuals
Smoker
Alcoholics and
Presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Corrected QT intervalTimepoint: between 1.5 to 3 hours after drug adminstration
- Secondary Outcome Measures
Name Time Method To determine independence of pharmacodynamic interaction from that of pharmacokinetic interactionTimepoint: At several time points during the study