| Pharmacokinetics and bioequivalence studies of galantamine hydrobromide dispersible tablet in healthy male Chinese volunteers. | |
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MedLine Citation:
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PMID: 17454066 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine hydrobromide dispersible tablet with that of conventional tablet. A single oral dose of 10 mg galantamine was administrated to each volunteer. Plasma concentrations of galantamine were determined by a validated high-performance liquid chromatography (HPLC) method with fluorescence detection, which allowed 1 ng/mL to be assayed as the lowest quantifiable concentration. From plasma concentrations, AUC(0-->t) (the area under the plasma concentration-time curve from time 0 to the last sampling time, 32 hr), AUC(0-->infinity) (the area under the plasma concentration-time curve from time 0 to infinity), t((1/2)) (elimination of half-life of the terminal log linear phase), C(max) (maximum plasma drug concentration) and T(max) (time to reach C(max)) were evaluated through noncompartmental pharmacokinetic analysis. AUC(0-->t) and AUC(0-->infinity) were calculated by the linear-log trapezoidal rule method. C(max) and T(max) were obtained directly from the plasma concentration-time curve. Analysis of variance was carried out using logarithmically transformed AUC(0-->t), AUC(0-->infinity) and C(max). As far as AUC(0-->t), AUC(0-->infinity) and C(max) were concerned, there was no statistically significant difference between the test and reference formulations. Ninety percent confidence intervals (90% CI) for the ratio of AUC(0-->t), AUC(0-->infinity) and C(max) values for the test and reference formulations were 100.4-107.8%, 99.0-107.2% and 87.5-111.3%, respectively. As the 90% CIs of AUC(0-->t), AUC(0-->infinity) and C(max) were entirely within 80-125%, two formulations were considered bioequivalent. |
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Authors:
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Li-jun Zhang; Xiao-ling Fang; Xue-ning Li; Qing-song Wang; Li-mei Han; Zhi-wen Zhang; Xian-yi Sha |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Drug development and industrial pharmacy Volume: 33 ISSN: 0363-9045 ISO Abbreviation: Drug Dev Ind Pharm Publication Date: 2007 Mar |
Date Detail:
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Created Date: 2007-04-24 Completed Date: 2007-05-31 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7802620 Medline TA: Drug Dev Ind Pharm Country: United States |
Other Details:
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Languages: eng Pagination: 335-40 Citation Subset: IM |
Affiliation:
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Department of Pharmaceutics, School of Pharmacy, Fudan University, Box 130, 138 Yi Xue Yuan Road, Shanghai, P. R. China. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Area Under Curve China Cholinesterase Inhibitors / blood, pharmacokinetics* Chromatography, High Pressure Liquid Cross-Over Studies Galantamine / blood, pharmacokinetics* Humans Male Tablets Therapeutic Equivalency |
| Chemical | |
Reg. No./Substance:
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0/Cholinesterase Inhibitors; 0/Tablets; 357-70-0/Galantamine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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