Campinas, Brazil
Campinas, Brazil

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The study was conducted to compare the bioavailability of two formulations of Desloratadine, considering test product as Desloratadine 1,25 mg/mL oral solution (Esalerg Gotas) (Aché Laboratórios Farmacêuticos S.A.) and reference product as Desalex® 0,5 mg/mL syrup (Mantecorp Chemical & Pharmaceuticals) in 48 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 the reference formulation. Blood samples were obtained throughout a 72 hours interval. The desloratadine concentrations were determined by mass spectrometry (UPLC-MS-MS) using donepezil as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: AUC0-t, AUC0-¥ and Cmax. The geometric mean of desloratadine / Desalex® were 95.42% for AUC0-t, 95.30% for AUC0-¥ and 90.61 % for Cmax. The 90% confidence intervals were 91.48 - 99.53% for AUC0-t, 91.18 - 99.61% for ASC0-¥ and 85.32 - 96.22% for Cmax. 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 oral solution of Desloratadine 1.25 mg/mL (Esalerg Gotas) was bioequivalent to 0,5 mg/mL syrup (Desalex®) and thus the test product may be considered interchangeable in medical practice. Copyright Moreira Jr. Editora. Todos os direitos reservados.


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.


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.


Abib Jr. E.,University of Medical Sciences of Costa Rica | Duarte L.F.,Scentryphar Pesquisa Clinica | Pereira R.,Scentryphar Pesquisa Clinica | Morais D.C.,Ache Laboratorios Farmaceuticos S.A | And 3 more authors.
Revista Brasileira de Medicina | Year: 2012

The study was conducted to compare the bioavailability of two formulations of ibandronate sodium 150 mg tablets (ibandronate sodium of Aché S/A testing and formulation of Bonviva® Roche Products Chemicals and Pharmaceuticals S.A. reference formulation, Brazil) in 80 volunteers of both sexes (20 female volunteers in post-menopausal, 20 volunteers sex femino not in menopause and 40 male volunteers). This was an open, replicated, randomized, two-sequence, four-period, crossover in two treatments, in which a group of volunteers received the test formulation and the other reference formulation. Plasma samples were obtained throughout a 72 hours interval. The concentrations of sodium ibandronate were determined by mass spectrometry (UPLC-MS-MS) using deuterated ibandronate as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: AUC 0-t, AUC 0-∞ and Cmax. The geometric mean of ibandronate sodium / Bonviva® 150 mg individual percent ratio were 102.18% for AUC 0-t, 102.14% for AUC 0-∞, and 100.64% for Cmax. The 90% confidence intervals were 94, 89-110.03%, 94.92-109.91%, 91.88-110.23%, respectively. Since the confidence intervals 90% for Cmax and AUC 0-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 sodium Thandronate 150 mg was bioequivalent to Bonviva® tablet of 150 mg and thus the test product may be considered interchangeable in medical practice. © Copyright Moreira Jr. Editora.


Abib Jr. E.,University of Medical Sciences of Costa Rica | Duarte L.F.,Scentryphar Pesquisa Clinica | Pereira R.,Scentryphar Pesquisa Clinica | Morais D.C.,Ache Laboratorios Farmaceuticos S.A. | And 3 more authors.
Revista Brasileira de Medicina | Year: 2012

The study was conducted to compare the bioavailability of two formulations of Risedronate Sodium 35 mg tablet (risedronate sodium of Aché S/A test formulation and Actonel® from Sanofi-Aventis Pharmaceuticals Inc. reference formulation, Brazil) in 80 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 96 hours interval. The risedronate sodium concentrations were determined by mass spectrometry (UPLC-MS-MS) using risedronic acid-D4 (deuterated risedronate) as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: AUC 0-t, AUC 0-∞ and Cmax. The geometric mean of risedronate sodium /Actonel ® 35 mg were 101.90% for AUCO-t, 97.95% for AUC 0-∞ and 100.70% for Cmax. The 90% confidence intervals were 86.43%-120.14%, 83.04%-115.54% and 85.50%-118.61%, 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 sodium risedronate 35 mg was bioequivalent to Actonel ® tablet of 35 mg and thus the test product may be considered interchangeable in medical practice. © Copyright Moreira Jr. Editora. Todos os direitos reservados.


Abib Jr. E.,University of Campinas | Duarte L.F.,Scentryphar Pesquisa Clinica | Pereira R.,Scentryphar Pesquisa Clinica | Morais D.C.,Ache Laboratorios Farmaceuticos S.A. | And 3 more authors.
Revista Brasileira de Medicina | Year: 2012

The study was conducted to compare the bioavailability of two formulations of rosuvastatin calcium 20 mg tablet (rosuvastatin calcium of Aché S/A test formulation and Crestor® from AstraZeneca do Brasil Ltda. reference formulation, Brazil) in 24 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 96 hours interval. The rosuvastatin calcium concentrations were determined by mass spectrometry (UPLC-MS-MS) using atorvastatin as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: AUC 0-t, AUC 0-∞ and Cmax. The geometric mean of rosuvastatin calcium/Crestor® 20 mg were 93,97% for AUC 0-t, 97,43% for AUC 0-∞ and 93,63% for Cmax. The 90% confidence intervals were 82,26-107,34%, 85,82-110,61% and 81,58-107,45%, respectively. Since the confidence intervals 90% for Cmax and AUC 0-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 rosuvastatin calcium 20 mg was bioequivalent to Crestor® tablet of 20 mg and thus the test product may be considered interchangeable in medical practice. © Copyright Moreira Jr. Editora.


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.


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.


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.


Abib Jr. 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 4 more authors.
Revista Brasileira de Medicina | Year: 2013

The study was conducted to compare the bioavailability of two formulations of donepezil hydrochloride 10.0 mg coated tablet (donepezil hydrochloride of Aché S/A test formulation and Eranz® from Wyeth Whitehall Ltda. reference formulation, Brazil) in 30 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 96 hours interval. The Donepezil concentrations were determined by mass spectrometry (UPLC-MS-MS) using Loratadine as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: ASC0-t, ASC0-∞ and Cmax. The geometric mean of Donepezil Hydrochloride / Eranz® 10.0 mg were 99,79% for ASC0-t, 101.44% for ASC0-∞ and 91.19% for Cmax. The 90% confidence intervals were 94.91-104.9%, 94.12-109.31% and 84.03-98.97%, respectively. Since the confidence intervals 90% for Cmax and ASC0-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 Donepezil Hydrochloride 10.0 mg was bioequivalent to Eranz® coated tablet of 10.0 mg and thus the test product may be considered interchangeable in medical practice. © Copyright Moreira Jr. Editora. Todos os direitos reservados.

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