Bioavailability of dissolved and crushed single tablets of bictegravir, emtricitabine, tenofovir alafenamide in healthy adults: the SOLUBIC randomized crossover study.

"Transparency declarations: L.H. reports personal fees and non-financial support from Gilead Sciences, personal fees and non-financial support from Janssen, personal fees and non-financial support from MSD, personal fees and non-financial support from ViiV Healthcare, outside the submitted work. I.M. is an employee and stockholder of Gilead Sciences. J.-J.P. reports grants and personal fees from ViiV Healthcare, personal fees from Gilead, grants and personal fees from MSD, outside the submitted work. All other authors: none to declare.: Author contributionsL.H., T.P., I.M. and J.-J.P. participated in the conception and design of the study. S.D., A.F., J.-J.P. included volunteers. A.A. prepared soluble and crushed tablets. C.V., S.B. and F.F. supervised volunteer’s care and blood sampling. L.P.-S.-P. oversaw pharmacovigilance. S.L., J.B. and L.G. carried out the pharmacological dosages. S.L., N.G. and J.-J.P. analysed and interpreted the data. L.H., S.L. and J.-J.P. wrote the manuscript. All authors reviewed, revised for consent, and approved the final version of this manuscript. All authors had full access to the data and are responsible for the veracity and completeness of the data reported. The corresponding author had final responsibility for the decision to submit for publication."

"Funding The SOLUBIC trial (study number CO-FR-380-5442) was funded by a grant from Gilead Sciences to Caen University hospital. Medication was donated by Gilead Sciences. The funder provided advice regarding the study design, drug preparation, data analysis and interpretation."

"The protocol was approved by the national ethics committee of Sud-Ouest et Outre-Mer 1 on 15 July 2019 and has been registered at ClinicalTrials.gov (NCT04244448). All participants provided written informed consent. The study was conducted in accordance with the Good Clinical Practice and ethical principles of the Declaration of Helsinki."