Entity

Time filter

Source Type

Campinas, Brazil

Abib E.,University of Medical Sciences of Costa Rica | Duarte L.F.,Scentryphar Pesquisa Clinica | Pereira R.,Scentryphar Pesquisa Clinica | Oliveira K.C.L.S.,Zodiac Produtos Farmaceuticos S A | And 3 more authors.
Revista Brasileira de Medicina | Year: 2014

The study was conducted to compare the bioavailability of two formulations of Cabergoline 0,5 mg tablets (Cabertrix® - test formulation and Dostinex® Laboratórios Pfizer Ltda, reference formulation) in 42 volunteers of both sexes (21 female volunteers and 21 male volunteers) in fasting condition. This was an open, randomized, two-sequence, two -period, crossover study, in which one group of volunteers received the test formulation and the other received reference formulation. Plasma samples were obtained throughout a 72 hours period after drug administration. The concentrations of cabergoline were determined by mass spectrometry (HPLC-MS-MS) using cabergoline-d5 as internal standard. From the data obtained, the following pharmacokinetics parameters were calculated: AUC0-t and Cmax. The Cabertrix/Dostinex 0,5 mg geometric mean ratio was 97.48% for AUC0-72h and 94.45% for Cmax. The 90% confidence intervals were 92.07 - 103.21% and 86.53 - 103.10%, respectively. Since the 90% confidence interval for Cmax and for AUC0-72h was within the range 80-125%, it was concluded that the tablet of Cabertrix® 0,5 mg was bioequivalent to Dostinex® tablet of 0,5mg in terms of rate and extent of absorption. © Copyright Moreira Jr. Editora. Todos os direitos reservados. Source


Abib E.,University of Medical Sciences of Costa Rica | Duarte L.F.,Scentryphar Pesquisa Clinica | Pereira R.,Scentryphar Pesquisa Clinica | Lemes A.B.,Scentryphar Pesquisa Clinica | And 3 more authors.
Revista Brasileira de Medicina | Year: 2014

The study was conducted to compare the bioavailability of two formulations of levofloxacin 500 mg tablet (levofloxacin of Aché S/A test formulation and Tavanic® from Sanofi-Aventis Farmacêutica Ltda. reference formulation, Brazil) in 28 volunteers both sexes. This was an open, randomized, two-sequence, two-period, crossover single dose two treatments, in which a group of volunteers received the test formulation and the other reference formulation. Blood samples were obtained throughout a 48 hours interval. The levofloxacin concentrations were determined by mass spectrometry (HPLC-MS-MS) using Ciprofloxacin as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: AUC0-t, AUC0-" and Cmax. The geometric mean of levofloxacin /Tavanic® 500 mg were 107.00% for AUC0-t, 107.07% for AUC0-" and 106.70% for Cmax. The 90% confidence intervals were 103.06-111.09%, 103.16-111.13% and 96.27-118.27%, respectively. Since the confidence intervals 90% for Cmax and AUC0-t was within the range 80-125% proposed by the FDA and ANVISA (National Agency of Sanitary Surveillance in Brazil), it is concluded that the tablet of Levofloxacin 500 mg was bioequivalent to Tavanic® tablet of 500 mg and thus the test product may be considered interchangeable in medical practice. Source


Abib E.,University of Medical Sciences of Costa Rica | Duarte L.F.,Scentryphar Pesquisa Clinica | Pereira R.,Scentryphar Pesquisa Clinica | Lemes A.B.,Scentryphar Pesquisa Clinica | And 8 more authors.
Revista Brasileira de Medicina | Year: 2015

The study was conducted to compare the bioavailability of fixed dose combination of memantine 20 mg and donepezil 10 mg coated tablet (Aché SA, test formulation), and Ebix® 10 mg coated tablet (Lundbeck Brazil Ltda, reference formulation) and Eranz® 10 mg coated tablet (Wyeth Pharmaceutical Industry Ltd., reference formulation) in 36 volunteers of both sexes. This was an open, randomized, two-treatment, two-sequence, two-period, crossover, single dose, in which a group of volunteers received the test formulation and other reference formulation. Blood samples were obtained throughout a 96 hours interval. The memantine combined donepezil concentrations were determined by mass spectrometry (UPLC-MS-MS) using amantadine and loratadine as internal standard. The geometric mean of memantine associated with donepezil/Ebix® 10 mg were 98.75% for AUC0-t and 96.95% for Cmax. The 90% confidence intervals were 96.01-101.58% and 93.50-100.54%, respectively. The geometric mean of memantine associated with donepezil / Eranz® 10 mg were 92.03% for AUC0-t and 94.77% for Cmax. The 90% confidence intervals were 89.47-94.67% and 88.22-101.80%, respectively. Since the confidence intervals 90% for Cmax and AUC0-t was within the range 80-125% proposed by the FDA and ANVISA (National Agency of Sanitary Surveillance in Brazil), it is concluded that the tablet of memantine 20 mg associated to donepezil 10 mg was bioequivalent to the concomitant administration of 2 tablets of Ebix® 10 mg and 1 tablet of Eranz® 10 mg and thus the test product may be considered interchangeable in medical practice. © Copyright Moreira Jr. Editora. Todos os direitos reservados. Source


Abib Jr. E.,University of Medical Sciences of Costa Rica | Abib Jr. E.,Dermaceive Research Institute | Duarte L.F.,Scentryphar Pesquisa Clinica | Duarte L.F.,Dermaceive Research Institute | And 6 more authors.
Revista Brasileira de Medicina | Year: 2012

The study was conducted to compare the bioavailability of two formulations of Valsartan 320 mg coated tablet (Valsartan of Aché S/A test formulation and Diovan® from Novartis Biociências S.A. reference formulation, Brazil) in 108 volunteers both sexes. This was an open, randomized, two-sequence, two-period, crossover single dose two treatments, in which a group of volunteers received the test formulation and the other reference formulation. Blood samples were obtained throughout a 48 hours interval. The Valsartan concentrations were determined by mass spectrometry (HPLC-MS-MS) using Losartan as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: AUC0-t, AUC0-∞ and Cmax. The geometric mean of Valsartan/Diovan® 320 mg were 103.63% for AUC1-t, 102.72% for AUC0-∞ and 102.96% for Cmax. The 90% confidence intervals were 96.24%-111.59%, 95.64%-110.34% and 95.51%-110.98%, respectively. Since the confidence intervals 90% for Cmax and AUC0-t. was within the range 80%-125% proposed by the FDA and ANVISA (National Agency of Sanitary Surveillance in Brazil), it is concluded that the coated tablet of Valsartan 320 mg was bioequivalent to Diovan® coated tablet of 320 mg and thus the test product may be considered interchangeable in medical practice. © Copyright Moreira Jr. Editora. Source


Abib Jr. E.,University of Medical Sciences of Costa Rica | Duarte L.F.,Scentryphar Pesquisa Clinica | Pereira R.,Scentryphar Pesquisa Clinica | Savio D.,R and D Labs S.r.l. | And 3 more authors.
Revista Brasileira de Medicina | Year: 2011

The study was performed to compare the bioavailability/bioequivalence of two Quetiapine 25 mg tablet formulations (Quetiapine from Aché Laboratórios Farmacêuticos S/A as test formulation and Seroquel® from Astrazeneca Ltda, Brazil, as reference formulation) in 48 volunteers of both sexes. The study was conducted as an open randomized two periods cross-over design with a wash out phase of one week. Plasma samples were obtained over a 36 hour interval. Plasma concentrations of Quetiapine were determined by LC-MS-MS equipment using Clozapine as internal standard. From the data obtained, the following pharmacokinetics parameters were calculated: AUC0-t′, AUC0-∞ and Cmax′ Geometric mean of Quetiapine/Seroquel® 25 mg was 99.96% for AUC 0-t′ 100.12% for AUC0-8 and 92.59% for C max′ the 90% confidence intervals were 93.58-106.77%, 93.88-106.78% and 83.22-103.01%, respectively. Since the 90% confidence intervals for Cmax′ AUC0-t and AUC 0-∞ were within the range of 80-125% proposed by Food and Drug Administration and ANVISA (the National Health Surveillance Agency of Brasil), it was concluded that Quetiapine 25 mg Tablet was bioequivalent to Seroquel® 25 mg tablet, and so the test product can be considered interchangeable in normal medical practice. © Copyright Moreira Jr. Editora. Todos os direitos reservados. Source

Discover hidden collaborations