Trial reportClinical pharmacology in drug development2026
Effect of High-Fat Diet on Pharmacokinetics and Incidence of Adverse Reactions of Tacrolimus in Healthy Chinese Participants.
Trial report in Clinical pharmacology in drug development, 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
8 authors.
Funding
Abstract
The effects of food on the pharmacokinetics (PKs) and safety of 1 mg Tacrolimus sustained-release Tacrolimus capsules in healthy Chinese subjects were investigated from one bioequivalence trial. The bioequivalence trial was designed as single-center, openlabel, randomized, single-dose, two-sequence, four-period crossover under both fasted and fed conditions. A total of 80 healthy subjects were enrolled. These subjects received a single oral 1 mg dose of Tacrolimus with a 14-day washout between four periods. Serial PK samples were collected and blood concentrations were analyzed using validated high-performance liquid chromatography-mass spectrometry. Pharmacokinetic parameters were calculated by noncompartmental methods. The BE module of WinNonLin was used for statistical analysis of the maximum concentration (C
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