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Abib Jr. E.,University of Campinas | Abib Jr. E.,Scentryphar Clinical Research | Duarte L.F.,Scentryphar Clinical Research | Suenaga E.M.,Federal University of Sao Paulo | And 2 more authors.
Journal of Bioequivalence and Bioavailability | Year: 2011

The study was performed to compare the bioavailability of two quetiapine 25 mg tablet formulations: the test formulation was quetiapine fumarate (kitapen®) manufactured by Cobalt Pharmaceuticals, Canada/ Arrow Farmacêutica Ltda* (Erowlabs). Seroquel® (quetiapine) from Astrazeneca Brazil was used as reference formulation. The study was conducted open with randomized two period crossover design and one week wash out period in 64 volunteers of both sexes. Plasma samples were obtained over a 48 hour interval. Quetiapine was analyzed by LC-MS-MS in the presence of quetiapine-D8 as internal standard. Plasma samples were obtained over a 48 hour interval. Quetiapine was analyzed by LC-MS-MS in the presence of quetiapine-D8 as internal standard. The mean ratio of parameters Cmax and AUC 0-t and 90% confidence intervals of correspondents were calculated to determine the bioequivalence. The means AUC 0-t for test and reference formulation were 432.41 ng.h/mL and 412.20 ng.h/mL, for AUC 0-∞ were 440.06 ng.h/mL and 418.90 ng.h/mL and, for Cmax 126.94 ng/mL and 108.71 ng/mL, respectively. Geometric mean of quetiapine (kitapen®)/Seroquel® 25 mg individual percent ratio was 97.68% AUC 0-t, 97.47% for AUC 0-∞ and 90.68% for C max. The 90% confidence intervals were 92.67 - 102.96%, 92.53 - 102.67%, 83.37 - 98.64%, respectively. Since the 90% confidence intervals for C max, AUC 0-t and AUC 0-∞ were within the 80 - 125% interval proposed by Food and Drug Administration, it was concluded that quetiapine (kitapen®) 25 mg tablet was bioequivalent to Seroquel® 25 mg tablet according to both the rate and extent of absorption. © 2011 Junior EA, et al. Source


Junior E.A.,Scentryphar Clinical Research | Junior E.A.,University of Campinas | Duarte L.F.,Scentryphar Clinical Research | de Oliveira D.A.,Scentryphar Clinical Research | And 6 more authors.
Latin American Journal of Pharmacy | Year: 2011

The study was performed to compare the bioavailability of two hydroxyzine hydrochloride 25 mg tablet formulation in 16 volunteers of both sexes. The study was conducted open with randomized two period crossover design and a two weeks wash out period. Plasma samples were obtained over a 96 h interval. Hydroxyzine concentrations were analyzed by Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS). Bioequivalence between the products was determined by calculating 90% confidence intervals (90% I.C) for the ratio of AUC0-t, AUC0-inf and Cmax values for the test and reference products, using logarithmic transformed data. The 90% confidence intervals were 81.89-105.85%, 84.61-105.30%, and 84.04-108.66%, respectively. Since the 90% confidence intervals for Cmax, AUC0-t and AUC0-inf were within the 80-125% interval proposed by the Food and Drug Administration, it was concluded that the two hydroxyzine hydrochloride formulations are bioequivalent in their rate and extent of absorption. Source


Abib Jr. E.,University of Campinas | Abib Jr. E.,Scentryphar Clinical Research | Duarte L.F.,Scentryphar Clinical Research | Pereira R.,Scentryphar Clinical Research
Journal of Public Budgeting, Accounting and Financial Management | Year: 2012

The study was performed to compare the bioavailability of two Pramipexole 0.125 mg tablet formulations: the test formulation was pramipezan® (pramipexole) manufactured by Cobalt Pharmaceuticals, Canada/ Arrow Farmacêutica Ltda*. Sifrol® (Pramipexole) from Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda was used as reference formulation. The study was conducted open with randomized two period crossover design and 8 days wash out period in 48 volunteers of both sexes. Plasma samples were obtained over a 48 hour interval. Pramipexole was analyzed by LC-MS-MS in the presence of Tansulosina as internal standard. The mean ratio of parameters Cmax. and AUC0-t and 90% confidence intervals of correspondents were calculated to determine the bioequivalence. The means AUC0-t for test and reference formulation were 8201.90 pg.h/mL and 7891.56 pg.h/mL, for AUC0-∞ were 8574.71 pg.h/mL and 8288.01 pg.h/mL and, for Cmax 642.09 pg/mL and 633.94 pg/mL, respectively. Geometric mean of pramipezan® (pramipexole) /Sifrol® 0.125 mg individual percent ratio was 103.61% AUC0-t, 103.13% for AUC0-∞ and 100.81% for Cmax. The 90% confidence intervals were 98.02 - 109.51%, 97.95 - 108.59%, 93.06 - 109.21%, respectively. Since the 90% confidence intervals for Cmax' AUC0-t and AUC0-∞ were within the 80 - 125% interval proposed by Food and Drug Administration, it was concluded that Pramipezan®(pramipexole) 0.125 mg tablet was bioequivalent to Sifrol®0.125 mg tablet according to both the rate and extent of absorption. © 2012 Abib E Jr, et al. Source


Junior E.A.,Scentryphar Clinical Research | Junior E.A.,University of Campinas | Duarte L.F.,Scentryphar Clinical Research | Vanunci M.L.P.,Scentryphar Clinical Research | And 4 more authors.
Latin American Journal of Pharmacy | Year: 2011

The present study was performed to compare the bioavailability of two digoxin 0.25 mg tablet formulation in 30 volunteers of both sexes. The study was conducted open with randomized two period crossover design and a three-week washout period. Plasma samples were obtained over a 144 h interval. Digoxin concentrations were analyzed by a validated microparticle enzyme immunoassay with optical detection by fluorescence. Bioequivalence between the products was determined by calculating 90 % confidence intervals (90 % I.C) for the ratio of AUC 0-72hand C max values for the test and reference products, using logarithmic transformed data. The 90 % confidence intervals were 86.98-118.33 %, and 84.52-98.76 %, respectively. Since the 90 % confidence intervals for C max and AUC 0-72hwere within the 80-125 % interval proposed by Food and Drug Administration, it was concluded that the two Digoxin formulations are bioequivalent in their rate and extent of absorption. Source


Abib Jr. E.,University of Campinas | Abib Jr. E.,Scentryphar Clinical Research | Duarte L.F.,Scentryphar Clinical Research | Pereira R.,Scentryphar Clinical Research | And 3 more authors.
Journal of Bioequivalence and Bioavailability | Year: 2011

The study was performed to compare the bioavailability of two gabapentin 400 mg capsule formulation (Gabapentin from Arrow Farmacêutica S/A as test formulation and Neurontin ® from Pfizer, Brazil, as reference formulation) in 26 volunteers of both sexes. The study was conducted open with randomized two period crossover design and a one week wash out period. Plasma samples were obtained over a 48 hour interval. The gabapentin was analyzed by LC/MS/MS, in the presence of pracetamole as internal standard. With plasma concentration vs. time curves, data obtained from this metabolite, the following pharmacokinetics parameters were obtained: AUC 0-t, AUC 0-inf and C max. Geometric mean of gabapentin/Neurontin ® 400 mg individual percent ratio was 100.58% AUC 0-t, 101.35% for AUC 0-inf and 97.76% for C max. The 90% confidence intervals were 92.00 - 109.95%, 93.00 - 110.44%, 88.41 - 108.10%, respectively. Since the 90% confidence intervals for C max, AUC 0-t and AUC 0 -inf were within the 80 - 125% interval proposed by Food and Drug Administration, it was concluded that gabapentin 400 mg capsule was bioequivalent to Neurontin ® 400 mg capsule according to both the rate and extent of absorption. © 2011 Junior EA, et al. Source

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