Source:http://linkedlifedata.com/resource/pubmed/id/20420791
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
5
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pubmed:dateCreated |
2010-4-27
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pubmed:abstractText |
Changes in bioavailability of anticonvulsant drugs such as topiramate may cause loss of or worsened seizure control. Thus, the purpose of this study was to evaluate, in a double-blind crossover design, the bioavailability between two oral formulations of topiramate in healthy volunteers after a single dose. The protocol, approved by the Institutional Committee of Ethics, consisted of administration of 1 tablet of 100 mg of topiramate of each formulation (Toprel and Topamax), to 20 healthy volunteers after a 12 h overnight fast, using an open, two-period, randomized, crossover and double-blind design. Thus, the plasma concentrations (Cp) of topiramate were measured at predetermined intervals of time, from 0 to 24 h, using a validated UPLC-MS/MS method. Based on plasma concentration-time profiles we obtained the following pharmacokinetic parameters: AUC(0-inf) 63,418.31 +/- 22,141.69 and 67,094.70 +/- 22,487.2 ngh/ml; AUC0-24: 30,421.02 +/- 9,964.0 and 30,489.35 +/- 9,407.17, ng x h/ml; tmax: 2.77 +/- 1.76 and 1.95 +/- 1.89 h; C(max): 2,143.33 +/- 724.26 and 2,262.51 +/- 751.12 ng/ml, for A (Toprel) and B (Topamax), respectively. All these differences were not statically significant with 90% confidence interval. The test of bioequivalence showed that Cmax, AUC(0-24) and AUC(0-inf) parameters are found within the range of 0.8 - 1.25 recommended by the FDA with a probability of bioequivalence of 100%. In accordance with these results, we can conclude that Toprel 100 mg, A (Test), is a bioequivalent generic and interchangeable with Topamax 100 mg, B (Reference).
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Anticonvulsants,
http://linkedlifedata.com/resource/pubmed/chemical/Drugs, Generic,
http://linkedlifedata.com/resource/pubmed/chemical/Fructose,
http://linkedlifedata.com/resource/pubmed/chemical/Tablets,
http://linkedlifedata.com/resource/pubmed/chemical/topiramate
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pubmed:status |
MEDLINE
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pubmed:month |
May
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pubmed:issn |
0946-1965
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
48
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
342-8
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pubmed:meshHeading |
pubmed-meshheading:20420791-Adult,
pubmed-meshheading:20420791-Anticonvulsants,
pubmed-meshheading:20420791-Area Under Curve,
pubmed-meshheading:20420791-Biological Availability,
pubmed-meshheading:20420791-Chromatography, Liquid,
pubmed-meshheading:20420791-Cross-Over Studies,
pubmed-meshheading:20420791-Double-Blind Method,
pubmed-meshheading:20420791-Drugs, Generic,
pubmed-meshheading:20420791-Female,
pubmed-meshheading:20420791-Fructose,
pubmed-meshheading:20420791-Humans,
pubmed-meshheading:20420791-Male,
pubmed-meshheading:20420791-Tablets,
pubmed-meshheading:20420791-Tandem Mass Spectrometry,
pubmed-meshheading:20420791-Therapeutic Equivalency,
pubmed-meshheading:20420791-Young Adult
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pubmed:year |
2010
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pubmed:articleTitle |
Relative bioavailability study with two oral formulations of topiramate using a validated UPLC-MS/MS method.
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pubmed:affiliation |
Laboratory of Pharmacokinetics and Bioavailability, IFT, Molecular and Clinical Pharmacology Program, Biomedical Sciences Institute, Faculty of Medicine, University of Chile, Santiago, Chile.
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pubmed:publicationType |
Journal Article,
Comparative Study,
Randomized Controlled Trial
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