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Charuwan Pradabsang
Charuwan Pradabsang
Thailand
Publications
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Research Article
Bioequivalence of a Generic Quetiapine (Ketipinor®) in Healthy Male Volunteers
Author(s): Werawath Mahatthanatrakul, Charuwan Pradabsang, Somchai Sriwiriyajan, Wibool Ridtitid and Malinee WongnawaWerawath Mahatthanatrakul, Charuwan Pradabsang, Somchai Sriwiriyajan, Wibool Ridtitid and Malinee Wongnawa
Quetiapine is an atypical antipsychotic indicated for the treatment of schizophrenia and related psychoses. Uses of generic drugs are essential due to economic reason. Interchangeability of drugs is determined by bioequivalence studies. We aim to study the bioequivalence of a generic quetiapine (Ketipinor ® , Orion Corporation, Finland) and the innovator product (Seroquel ® , AstraZeneca, UK). The study was a randomized, two-way crossover design with a two-week washout period in 24 healthy Thai male volunteers. After a single 200-mg oral dosing, serial blood samples were collected at appropriate interval up to 48 h. Plasma quetiapine concentrations were determined by using a validated LC-MS/MS method. Pharmacokinetic parameters were estimated using the WinNonlin ® software with non- compartment model analysis. The mean ± SD of maximum plasma concentration (C max ), .. View More»
DOI: 10.4172/jbb.1000069