Analysis of Crushed and Whole Tablet Genvoya

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.

Timeline

Start

2019-04-15

Primary completion

2021-11-01

Completion

2021-11-01

Publications

• Andrade A, Fuchs EJ, Marzinke MA, Abdul Massih S, Breakey J, Beselman S, McNicholl I, Hendrix CW. EVG/COBI/FTC/TAF Bioequivalence Comparing Whole Tablets with Tablets Dissolved in Tap Water. AIDS Res Hum Retroviruses. 2023 Jan;39(1):38-43. doi: 10.1089/AID.2022.0085. Epub 2022 Dec 22.

Drugs

Indications

No indication recorded.