The purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Miami, Florida, United States
Maximum observed plasma concentration (Cmax)
Time frame: Up to 17 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 17 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 17 days
Apparent terminal plasma half-life (T-HALF)
Time frame: Up to 17 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
Time frame: Up to 17 days
Observed plasma concentration at 24 hours (C24)
Time frame: Up to 17 days
Number of participants with Adverse Events (AEs)
Time frame: Up to 75 days
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 75 days
Number of participants with AEs leading to discontinuation
Time frame: Up to 75 days
Number of participants with AEs leading to death
Time frame: Up to 75 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 17 days
Number of participants with vital sign abnormalities
Time frame: Up to 17 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 17 days
Changes in Taste Evaluation Questionnaire
Palatability evaluated on a scale from 1 (weak) to 9 (strong)
Time frame: Up to 17 days
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