Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat

Exclusion Criteria

• •Any significant acute or chronic medical illness
• •Current or recent (within 3 months of study drug administration) gastrointestinal tract disease
• •Any major surgery within 4 weeks of study drug administration
• •Any gastrointestinal tract surgery (including cholecystectomy) that could have an impact on the absorption of study drug
• •Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
• •Blood transfusion within 4 weeks of study drug administration
• •Inability to tolerate oral medication, to be venipunctured, or to tolerate venous access
• •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination or electrocardiogram (ECG) findings, vital sign measurements, or results of clinical laboratory tests, beyond what is consistent with the target population
• •Any of the following 12-lead ECG findings prior to study drug administration, confirmed by repeat testing
• •* PR ≥210 msec
• •* QRS ≥120 msec
• •* QT ≥500 msec
• •* QTcF ≥450 msec
• •2nd- or 3rd-degree A-V block or clinically relevant abnormalities in ECG findings
• •Positive result on urine screening for drugs of abuse
• •Positive result on blood screening for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 or -2 antibody
• •Laboratory test results indicating levels outside of the ranges specified below:
• •* Alanine aminotransferase \>upper limit of normal (ULN)
• •* Aspartate aminotransferase \>ULN
• •* Total bilirubin \>ULN
• •* Serum creatinine \>ULN