CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 12 enrolled
Drug / intervention
Genvoya Oral dose +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03717129
NCT03717129Phase 4Completed
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Bioequivalence of Crushed and Whole Genvoya Tablets (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fumarate)

Johns Hopkins University·interventional·Posted Oct 24, 2018·Updated Jan 31, 2023

In Brief

A Phase 4 clinical trial evaluating Genvoya Oral dose and Genvoya Crushed Dose for Healthy Volunteers. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedOct 24, 2018
Enrollment StartApr 15, 2019
Primary CompletionNov 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.7 years ago

Interventions

Genvoya Oral dosedrug

Single Genvoya oral dose directly observed

Genvoya Crushed Dosedrug

Single Genvoya crushed tablet in water directly observed