Trial reportNaunyn-Schmiedeberg's archives of pharmacology2026
Pharmacokinetics and safety of a new free-base formulation of tenofovir alafenamide 25 mg in healthy volunteers: a randomized, open-label, four-period, fully replicated crossover bioequivalence study.
Trial report in Naunyn-Schmiedeberg's archives of pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
6 authors.
Funding
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Abstract
This study compared the pharmacokinetic bioequivalence and safety of a new free-base formulation of 25 mg tenofovir alafenamide (TAF) to those of a reference formulation under fasting conditions. In this phase I, randomized, open-label, two-sequence, four-period, fully replicated crossover trial, 48 healthy volunteers were enrolled to receive single doses of the test and reference formulations in the T-R-T-R or R-T-R-T sequences. The plasma concentrations of TAF and tenofovir were measured and analyzed using non-compartmental methods. As the TAF concentration exhibits high intra-individual variability, reference-scaled average bioequivalence can be applied. The safety and tolerability were monitored during the study. All 48 volunteers received the study drug at least once. The pharmacokinetic analysis included 44 and 46 volunteers for TAF and tenofovir, respectively. The intra-individual coefficient of variation for the plasma maximum concentration (C
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