The purpose of this study is to evaluate the single-dose pharmacokinetics and relative bioavailability of Darunavir (DRV) 800 milligram (mg), Cobicistat (COBI) 150 mg, Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed-dose combination (FDC) (D/C/F/TAF) tablet in healthy adult participants when given as Treatment A (reference): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet swallowed as a whole, intact tablet with 240milliliter (mL) of noncarbonated water.Treatment B (test): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a split tablet swallowed with 240 mL of noncarbonated water. Treatment C (test): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a crushed tablet mixed in 4 ounces (oz) of applesauce.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Darunavir 800 milligram (mg) will be taken orally in FDC together with COBI(150mg)/FTC(200mg)/TAF(10mg).
Cobicistat 150 milligram (mg) will be taken orally in FDC together with DRV(800mg)/FTC(200mg)/TAF(10mg).
Emtricitabine 200 milligram (mg) will be taken orally in FDC together with COBI(150mg)/DRV(800mg)/TAF(10mg).
Tenofovir Alafenamide 10 milligram (mg) will be taken orally in FDC together with COBI(150mg)/FTC(200mg)/DRV(800mg).
Unnamed facility
Tempe, Arizona, United States
Maximum Observed Plasma Concentration (Cmax)
Cmax is defined as the maximum observed plasma concentration.
Time frame: Up to Day 4
Area Under the Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last])
AUC (0-last) is the area under the Plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \[non BQL\]) concentration, calculated by linear trapezoidal summation.
Time frame: Up to Day 4
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
The AUC (0-infinity) is the area under the plasma concentration time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Time frame: Up to Day 4
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Screening (21 days ) to End of the study (7 to 10 days after the last dose)
Number of Participants With Clinical Laboratory Results as a Measure of Safety and Tolerability
Time frame: Screening (21 days ) to End of the study (7 to 10 days after the last dose)
Number of Participants With Vital Signs as a Measure of Safety and Tolerability
Time frame: Screening (21 days ) to End of the study (7 to 10 days after the last dose)
Number of Participants With Physical Examination Findings as a Measure of Safety and Tolerability
Time frame: Screening (21 days ) to End of the study (7 to 10 days after the last dose)
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