Pharmacokinetics and Bioequivalence Evaluation of Cyclobenzaprine Tablets
Joint Authors
Serra, Cristina Helena dos Reis
Brioschi, Tatiane Maria de Lima Souza
Schramm, Simone Grigoleto
Kano, Eunice Kazue
Koono, Eunice Emiko Mori
Ching, Ting Hui
Porta, Valentina
Source
Issue
Vol. 2013, Issue 2013 (31 Dec. 2013), pp.1-6, 6 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2013-09-16
Country of Publication
Egypt
No. of Pages
6
Main Subjects
Abstract EN
The purpose of this study was to investigate cyclobenzaprine pharmacokinetics and to evaluate bioequivalence between two different tablet formulations containing the drug.
An open, randomized, crossover, single-dose, two-period, and two-sequence design was employed.
Tablets were administered to 23 healthy subjects after an overnight fasting and blood samples were collected up to 240 hours after drug administration.
Plasma cyclobenzaprine was quantified by means of an LC-MS/MS method.
Pharmacokinetic parameters related to absorption, distribution, and elimination were calculated.
Cyclobenzaprine plasma profiles for the reference and test products were similar, as well as absorption pharmacokinetic parameters AUC (reference: 199.4 ng∗h/mL; test: 201.6 ng∗h/mL), Cmax (reference: 7.0 ng/mL; test: 7.2 ng/mL), and Tmax (reference: 4.5 h; test: 4.6 h).
Bioequivalence was evaluated by means of 90% confidence intervals for the ratio of AUC (93%–111%) and Cmax (93%–112%) values for test and reference products, which were within the 80%–125% interval proposed by FDA.
Cyclobenzaprine pharmacokinetics can be described by a multicompartment open model with an average rapid elimination half-life (t(1/2)β) of 3.1 hours and an average terminal elimination half-life (t(1/2)γ) of 31.9 hours.
American Psychological Association (APA)
Brioschi, Tatiane Maria de Lima Souza& Schramm, Simone Grigoleto& Kano, Eunice Kazue& Koono, Eunice Emiko Mori& Ching, Ting Hui& Serra, Cristina Helena dos Reis…[et al.]. 2013. Pharmacokinetics and Bioequivalence Evaluation of Cyclobenzaprine Tablets. BioMed Research International،Vol. 2013, no. 2013, pp.1-6.
https://search.emarefa.net/detail/BIM-1030287
Modern Language Association (MLA)
Brioschi, Tatiane Maria de Lima Souza…[et al.]. Pharmacokinetics and Bioequivalence Evaluation of Cyclobenzaprine Tablets. BioMed Research International No. 2013 (2013), pp.1-6.
https://search.emarefa.net/detail/BIM-1030287
American Medical Association (AMA)
Brioschi, Tatiane Maria de Lima Souza& Schramm, Simone Grigoleto& Kano, Eunice Kazue& Koono, Eunice Emiko Mori& Ching, Ting Hui& Serra, Cristina Helena dos Reis…[et al.]. Pharmacokinetics and Bioequivalence Evaluation of Cyclobenzaprine Tablets. BioMed Research International. 2013. Vol. 2013, no. 2013, pp.1-6.
https://search.emarefa.net/detail/BIM-1030287
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1030287