Overview

Analysis of Crushed and Whole Tablet Genvoya

Status:
Completed
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
Step-wise, two sequential, single-dose, bioequivalence study in 12 healthy volunteers to determine whether crushed Genvoya tablet is bioequivalent to whole Genvoya tablet. The first study sequence will involve a directly observed single dose of the fixed dose formulation of whole Genvoya tablet, with semi-intensive pharmacokinetic serum sampling at time points following the dose. After a washout period of seven days, subjects will then receive a directly observed single dose of a crushed tablet of Genvoya with subsequent semi-intensive pharmacokinetic serum sampling.
Phase:
Phase 4
Details
Lead Sponsor:
Johns Hopkins University
Collaborator:
Gilead Sciences
Treatments:
Cobicistat
Elvitegravir
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Emtricitabine
Emtricitabine tenofovir alafenamide
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Tenofovir