Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination

PHASE1CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

June 1, 2015

Primary Completion Date

August 14, 2015

Study Completion Date

August 14, 2015

Conditions
Healthy
Interventions
DRUG

Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

DRUG

Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

A tablet containing EVG 150 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

DRUG

Darunavir

A tablet containing Darunavir (DRV) 800 mg will be administered.

DRUG

Emtricitabine/Tenofovir alafenamide (FTC/TAF)

A tablet containing Emtricitabine (FTC) 200 mg and Tenofovir alafenamide (TAF) 10 mg will be administered.

DRUG

Cobicistat

A tablet containing cobicistat (COBI) 150 mg will be administered.

OTHER

High-fat Breakfast

High-fat breakfast will be administered.

OTHER

Standardized Regular Breakfast

Standardized regular breakfast will administered.

Trial Locations (1)

Unknown

Antwerp

All Listed Sponsors
lead

Janssen Sciences Ireland UC

INDUSTRY

NCT02475135 - Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination | Biotech Hunter | Biotech Hunter