scholarly journals Pharmacokinetic Interaction between Faldaprevir and Cyclosporine or Tacrolimus in Healthy Volunteers: A Prospective, Open-Label, Fixed-Sequence, Crossover Study

2018 ◽  
Vol 123 (1) ◽  
pp. 84-93 ◽  
Author(s):  
Fenglei Huang ◽  
Claudia Voelk ◽  
Matthias Trampisch ◽  
Lois Rowland ◽  
Armin Schultz ◽  
...  
Keyword(s):  
Crossover Study ◽  
Healthy Volunteers ◽  
Pharmacokinetic Interaction ◽  
Open Label ◽  
Fixed Sequence

Effect of Steady-State Faldaprevir on Pharmacokinetics of Atorvastatin or Rosuvastatin in Healthy Volunteers: A Prospective Open-Label, Fixed-Sequence Crossover Study

2017 ◽  
Vol 57 (10) ◽  
pp. 1305-1314 ◽  
Author(s):  
Fenglei Huang ◽  
Kristell Marzin ◽  
Rüdiger Koenen ◽  
Klaus Peter Kammerer ◽  
Natalja Strelkowa ◽  
...  
Keyword(s):  
Steady State ◽  
Crossover Study ◽  
Healthy Volunteers ◽  
Open Label ◽  
Fixed Sequence

Pharmacokinetics and Safety of Coadministered Oseltamivir and Rimantadine in Healthy Volunteers: An Open-Label, Multiple-Dose, Randomized, Crossover Study

2012 ◽  
Vol 52 (8) ◽  
pp. 1255-1264 ◽  
Author(s):  
Georgina Cirrincione-Dall ◽  
Barbara J. Brennan ◽  
Rosa M. Ballester-Sanchis ◽  
Mercidita T. Navarro ◽  
Brian E. Davies
Keyword(s):  
Crossover Study ◽  
Healthy Volunteers ◽  
Multiple Dose ◽  
Open Label ◽  
Randomized Crossover Study

Influence of food on the oral bioavailability of rupatadine tablets in healthy volunteers: A single-dose, randomized, open-label, two-way crossover study

2007 ◽  
Vol 29 (5) ◽  
pp. 900-908 ◽  
Author(s):  
Anna Solans ◽  
Marcel·lí Carbó ◽  
Juana Peña ◽  
Teresa Nadal ◽  
Iñaki Izquierdo ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Healthy Volunteers ◽  
Oral Bioavailability ◽  
Open Label ◽  
Influence Of Food

scholarly journals An open-label, randomized, single intravenous dosing study to investigate the effect of fixed dose combinations of tenofovir/lamivudine or atazanavir/ritonavir on the pharmacokinetics of remdesivir in Ugandan healthy volunteers (RemTLAR)

2021 ◽  
Author(s):  
Stephen Ian Walimbwa ◽  
Julian Paul Kaboggoza ◽  
Catriona Waitt ◽  
Pauline Byakika-Kibwika ◽  
Antonio D'Avolio ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Healthy Volunteers ◽  
Emerging Infectious Diseases ◽  
Crossover Design ◽  
Fixed Dose ◽  
Open Label ◽  
Fixed Sequence ◽  
Blood Samples ◽  
Treatment Regimens ◽  
Drug Concentrations

Abstract Background: Remdesivir is a novel broad-spectrum antiviral therapeutic with activity against several viruses that cause emerging infectious diseases. The purpose of this study is to explore how commonly utilized antiretroviral therapy (tenofovir disoproxil fumarate /lamivudine [TDF/3TC] and atazanavir/ritonavir [ATV/r]) influence plasma and intracellular concentrations of remdesivir. Methods: This is an open label, randomized, fixed sequence single intravenous dosing study to assess pharmacokinetic interactions between remdesivir and TDF/3TC (Study A, Crossover design) or TDF/3TC plus ATV/r (Study B). Healthy volunteers satisfying study entry criteria will be enrolled in the study and randomized to either Study A; N=16 (Sequence 1 or Sequence 2) or Study B; N=8. Participants will receive standard adult doses of antiretroviral therapy for seven days and a single 200mg remdesivir infusion administered over 60 minutes. Pharmacokinetic blood sampling will be performed relative to start of remdesivir infusion; predose (before start of remdesivir infusion) and 30 minutes after start of remdesivir infusion. Additional blood samples will be taken at 2, 4, 6, 12 and 24 hours after end of remdesivir infusion. Discussion: This study will characterize the pharmacokinetics of remdesivir from a typical African population in whom clinical use is anticipated. Furthermore, this study will deliver pharmacokinetic datasets for remdesivir drug concentrations and demographic characteristics which could support pharmacometric approaches for simulation of remdesivir treatment regimens in patients concurrently using tenofovir/lamivudine and/or atazanavir/ritonavir. Trial registration: ClinicalTrials.gov, ID:NCT04385719

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