The purpose of this study is to evaluate the single-dose pharmacokinetic (PK) and bioequivalence of Darunavir (DRV) in the presence of Cobicistat (COBI) when administered as a DRV/COBI fixed dose combination (FDC) tablet dispersed in water compared to the co-administration of the separate available formulations (DRV suspension and COBI tablet) under fed conditions in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
32
Participants will receive a single oral dose of DRV/COBI FDC tablet dispersed in water as per assigned treatment sequence.
Participants will receive a single oral dose of COBI tablet as per assigned treatment sequence.
Participants will receive single oral dose of DRV suspension as per the assigned treatment sequence.
SGS Belgium NV
Edegem, Belgium
Maximum Observed Plasma Concentration (Cmax) of Darunavir (DRV)
Cmax is defined as the maximum observed plasma concentration of DRV.
Time frame: Pre dose, up to 72 hours post dose (up to Day 4)
Area Under the DRV Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) of DRV
AUC (0-last) is the area under the DRV concentration-time curve from time zero to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.
Time frame: Pre dose, up to 72 hours post dose (up to Day 4)
Area Under the DRV Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of DRV
AUC (0-infinity) is the area under the DRV concentration-time curve from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z).
Time frame: Pre dose, up to 72 hours post dose (up to Day 4)
Maximum Observed Plasma Concentration (Cmax) of Cobicistat (COBI)
Cmax is defined as the maximum observed plasma concentration of COBI.
Time frame: Pre dose, up to 72 hours post dose (up to Day 4)
Area Under the COBI Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) of COBI
AUC (0-last) is the area under the COBI concentration-time curve from time zero to the time of the last measurable (non-BQL) concentration, calculated by linear-linear trapezoidal summation.
Time frame: Pre dose, up to 72 hours post dose (up to Day 4)
Area Under the COBI Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of COBI
AUC (0-infinity) is the area under the COBI concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z), wherein AUC(0-last) is area under the COBI concentration-time curve from time zero to the time of last measurable non-BQL concentration, C(last) is the last observed measurable (non-BQL) concentration, and lambda(z) is apparent terminal elimination rate constant.
Time frame: Pre dose, up to 72 hours post dose (up to Day 4)
Number of Participants With Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (the participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe.); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Time frame: Up to 7 weeks
Number of Participants with Abnormalities in Physical Examinations
Number of participants with abnormalities in physical examinations (including skin examination, body weight, height and family history related to skin disease) will be reported.
Time frame: Up to 7 weeks
Number of Participants with Abnormalities in Vital Sign Measurements
Number of participants with abnormalities in vital sign measurements (including temperature, pulse/heart rate, systolic and diastolic blood pressure) will be reported.
Time frame: Up to 7 weeks
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and random urine samples) will be reported.
Time frame: Up to 7 weeks
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