Trial reportDrug design, development and therapy2025
Pharmacokinetics and Safety with Bioequivalence of Isosorbide Mononitrate Sustained-Release Tablets in Chinese Healthy Volunteers: Bioequivalence Study.
Trial report in Drug design, development and therapy, 2025. 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.
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Authors and funding
10 authors.
Funding
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Abstract
Purpose: Isosorbide mononitrate was recommended for controlling anginal symptoms in patients with cardiovascular disease. We aimed to compare the pharmacokinetics, bioequivalence and safety of two formulations of oral isosorbide mononitrate sustained-release tablets in healthy Chinese volunteers. Subjects and Methods: A randomized, open-label, two-period, single-center, single-dose clinical trial with crossover design was conducted in Zhejiang Hospital. Subjects received single dose 40-mg/tablet isosorbide mononitrate in each period with a 5-day washout. Serial blood samples were collected over 36 hours post-dose (Days 1 and 6). The plasma concentrations of isosorbide mononitrate were measured using a high-performance liquid chromatography-tandem mass spectrometry method, and pharmacokinetic parameters were determined using noncompartmental methods. Results: Fifty-six healthy subjects were enrolled. In the fasting group, the maximum plasma concentration (C Conclusion: The isosorbide mononitrate sustained-release tablet demonstrated bioequivalence to the reference formulation (Ismo
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