Health Condition 1: null- Renal failure patients whose creatinine clearance is 10-50 ml/min
Conditions
Interventions
Intervention1: Voriconazole and Moxifloxacin combination: Single dose administration of moxifloxacin in a dose of 400 mg or single dose orally along with administration of voriconazole in a dose of 40
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Corrected QT intervalTimepoint: between 1.5 to 3 hours after drug adminstration | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine independence of pharmacodynamic interaction from that of pharmacokinetic interactionTimepoint: At several time points during the study | — |
Countries
India
Contacts
Public Contactdr pankaj maheshwari
PGIMER. Chandigarh
Outcome results
None listed