Bioequivalence of Solid/Crushed/Dissolved Forms of Biktarvy®

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

December 2, 2019

Primary Completion Date

April 24, 2021

Study Completion Date

May 31, 2021

Conditions
Healthy Volunteers
Interventions
DRUG

receive dissolved form of BIKTARVY®

The healthy volunteers will receive dissolved form of BIKTARVY® Pharmacokinetic samples will be taken at the following times: 0 hour (right before taking Biktarvy®); 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 8 hours; 12 hours; 24 hours; 36 hours; 48 hours and 72 hours (after Biktarvy®).

DRUG

receive crushed form of BIKTARVY®

The healthy volunteers will receive crushed form of BIKTARVY® Pharmacokinetic samples will be taken at the following times: 0 hour (right before taking Biktarvy®); 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 8 hours; 12 hours; 24 hours; 36 hours; 48 hours and 72 hours (after Biktarvy®).

DRUG

receive solid form of BIKTARVY®

The healthy volunteers will receive solid form of BIKTARVY® Pharmacokinetic samples will be taken at the following times: 0 hour (right before taking Biktarvy®); 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 8 hours; 12 hours; 24 hours; 36 hours; 48 hours and 72 hours (after Biktarvy®).

Trial Locations (1)

14033

CHU de Caen, Caen

All Listed Sponsors
lead

University Hospital, Caen

OTHER

NCT04244448 - Bioequivalence of Solid/Crushed/Dissolved Forms of Biktarvy® | Biotech Hunter | Biotech Hunter