Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects

Exclusion Criteria

• •1. Positive serum pregnancy test at screening or positive urine pregnancy test
• •2. Having taken NTZ at any time prior to the first study drug administration
• •3. History of alcohol abuse within 1 year prior to screening
• •4. History of drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening
• •5. Excessive consumption of xanthine-based drinks (\> 4 cups or glasses per day), food or beverages containing xanthine derivatives or xanthine-based compounds, 48 hours prior to the first dosing
• •6. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to the first dosing
• •7. Strenuous exercise within 72 hours prior to check-in
• •8. History of a major surgical procedure within 30 days prior to screening
• •9. Presence or history of malignancy within the prior 3 years, with the exception of treated basal cell or squamous cell carcinoma
• •10. Poor peripheral venous access
• •11. Subjects who are taking warfarin or other highly plasma protein-bound drugs with narrow therapeutic indices