About: Pharmacokinetic properties and bioequivalence of two formulations of arbidol: An open-label, single-dose, randomized-sequence, two-period crossover study in healthy chinese male volunteers

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About: Pharmacokinetic properties and bioequivalence of two formulations of arbidol: An open-label, single-dose, randomized-sequence, two-period crossover study in healthy chinese male volunteers Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Pharmacokinetic properties and bioequivalence of two formulations of arbidol: An open-label, single-dose, randomized-sequence, two-period crossover study in healthy chinese male volunteers
Creator	Wang, Shuang Liu, Ming-Yan Meng, Sheng-Nan Wei, Min-Jie Yao, Wei-Fan Wu, Hui-Zhe
Source	Elsevier; Medline; PMC
abstract	Abstract Background: Arbidol is an antiviral drug indicated for the prevention and treatment of all types of influenza infection and some other kinds of acute respiratory infections, specifically against influenza groups A and B, and severe acute respiratory syndrome. It is used to help prevent influenza infection as long as necessary with little risk for influenza mutation rendering it less effective. Objective: The aim of this study was to compare the pharmacokinetic properties and tolerability, and to determine bioequivalence, of a newly developed generic dispersible tablet formulation (test) and a branded capsule formulation (reference) of arbidol 200 mg in healthy Chinese fasted male volunteers. Methods: This open-label, single-dose, randomized-sequence, 2-period crossover study was conducted in healthy native Chinese male volunteers. Eligible subjects were randomly assigned in a 1:1 ratio to receive a single 200-mg dose of the test or reference formulation, followed by a 1-week washout period and administration of the alternate formulation. The study drugs were administered after a 12-hour overnight fast. After the study drug administration, serial blood samples were collected for 72 hours after administration. Plasma drug concentrations were determined using high-performance liquid chromatography coupled with tandem mass spectrometry. Several pharmacokinetic pararameters, including Cmax, Tmax, t½, AUC0-t, and AUC0-∞, were determined from the plasma concentrations of the 2 formulations of arbidol using noncom-partmental analysis. The formulations were to be considered bioequivalent if the log-transformed ratios of Cmax and AUC were within the predetermined bioequivalence range of 80% to 125% established by the State Food and Drug Administration (SFDA) of the People's Republic of China. Tolerability was assessed by monitoring vital signs (blood pressure, heart rate, temperature, and electrocardiography), laboratory analysis (hematology, blood biochemistry, hepatic function, and urinalysis), and subject interview on adverse events. Results: Twenty subjects were enrolled and completed the study (mean [SD] age, 21.1 [1.1] years; weight, 64.7 [5.1] kg; and height, 172.3 [3.1] cm). Neither period nor sequence effect was observed. The main pharmacokinetic properties with the test and reference formulations were as follows: Cmax, 417.4 (107.6) and 414.8 (95.1) ng/mL, respectively (P = NS); median (range) Tmax, 0.63 (0.25–1.0) and 0.75 (0.5–1.5) hours (P = 0.035); AUC0-t, 2033.6 (564.9) and 1992.0 (483.3) ng/mL/h (P = NS); AUC0-∞, 2285.4 (597.7) and 2215.2 (604.0) ng/mL/h (P = NS); and t1/2, 6.9 (4.2) and 6.1 (5.2) hours (P = NS). The 90% CIs for the log-transformed ratios of Cmax, AUC0-t, and AUC0-∞ were 91.7% to 109.7%, 91.0% to 112.8%, and 92.0% to 116.3%, respectively (all, P < 0.05), which were within the predetermined range for bioequivalence. No adverse events were found on analysis of vital signs or laboratory tests or reported by subjects in this study. Conclusion: In this study in healthy Chinese male volunteers, the dispersible tablet formulation and the 200-mg capsule formulation of arbidol met the SFDA's regulatory definition of bioequivalence based on the rate and extent of absorption.
has issue date	2009-04-30(xsd:dateTime)
bibo:doi	10.1016/j.clinthera.2009.04.016
bibo:pmid	19446151
has license	els-covid
sha1sum (hex)	e065a599f1d442a1813834cfeadeea1869670370
schema:url	https://doi.org/10.1016/j.clinthera.2009.04.016
resource representing a document's title	Pharmacokinetic properties and bioequivalence of two formulations of arbidol: An open-label, single-dose, randomized-sequence, two-period crossover study in healthy chinese male volunteers
has PubMed Central identifier	PMC7133634
has PubMed identifier	19446151
schema:publication	Clinical Therapeutics
resource representing a document's body	covid:e065a599f1d442a1813834cfeadeea1869670370#body_text
is schema:about of	named entity 'influenza' named entity 'rendering' covid:arg/e065a599f1d442a1813834cfeadeea1869670370 named entity 'antiviral drug' named entity 'long' named entity 'influenza infection' named entity 'acute respiratory infections' named entity 'Arbidol' named entity 'severe acute respiratory syndrome' named entity 'influenza' named entity 'Pharmacokinetic' named entity 'ANOVA' named entity 'hematologic' named entity 'Pharmacokinetic' named entity 'diethyl ether' named entity 'St. Louis' named entity 'pharmacokinetic' named entity 'Millipore' named entity 'kidneys' named entity 'China' named entity 'arbidol' named entity 'Fairfield, Ohio' named entity 'blood center' named entity 'Affiliated Hospital' named entity 'linear regression' named entity 'research involving human subjects' named entity 'selected ion monitoring' named entity 'Shiseido' named entity 'Plasma' named entity 'drug administration' named entity 'allergic reaction' named entity 'beer' named entity 'urinalysis' named entity 'internal standard' named entity 'generic formulation' named entity 'influenza' named entity 'adverse events' named entity 'room temperature' named entity 'open-label' named entity 'arbidol' named entity 'room temperature' named entity 'China Medical University' named entity 'staple food' named entity 'Formic acid' named entity 'arbidol' named entity '4.2' named entity 'bioequivalence' named entity 'sodium carbonate' named entity 'drug administration' named entity 'State Food and Drug Administration' named entity 'pneumonia' named entity 'lipid membranes' named entity 'diarrhea' named entity 'Liuyuan' named entity 'clinical protocol' named entity 'pneumonia' named entity 'precision, accuracy' named entity 'Research and Development' named entity 'plasma' named entity 'voltage' named entity 'arbidol' named entity 'ANOVA' named entity 'clinical pharmacist' named entity 'hematology' named entity 'bronchitis' named entity 'catheter' named entity 'medical history' named entity 'People's Republic of China' named entity 'diazepam' named entity 'vital sign' named entity 'hepatic' named entity 'HPLC-MS' named entity 'Declaration of Helsinki' named entity 'bioequivalence' named entity 'phagocytic activity' named entity 'heparin'

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