Eduardo Abib Junior

Average bioequivalence of single 500 mg doses of two oral formulations of levofloxacin: a randomized, open-label, two-period crossover study in healthy adult Brazilian volunteers

A bioequivalencia media de duas formulacoes de levofloxacino disponiveis no Brasil, Tavanic(c) (Sanofi-Aventis Farmaceutica Ltda, Brasil, produto referencia) e Levaquin(c) (Janssen-Cilag Farmaceutica Ltda, Brasil, produto teste) foi determinada por meio da realizacao de ensaio aleatorio, aberto, cruzado, com dois periodos e duas sequencias, em 26 voluntarios sadios em condicoes de jejum. Amostras de sangue dos voluntarios foram obtidas ao longo de um periodo de 48 horas apos administracao de dose unica de 500 mg de levofloxacino. As concentracoes plasmaticas do farmaco foram determinadas por metodo cromatografico validado. Os parâmetros farmacocineticos Cmax, Tmax, Kel, T1/2el, AUC0-t e AUC0-inf foram calculados por analise nao compartimental. A bioequivalencia foi determinada pelo calculo de intervalos de confianca 90% (IC 90%) para as razoes entre os valores de Cmax, AUC0-t e AUC0-inf obtidos para os produtos teste e referencia, usando dados transformados logaritmicamente. A tolerabilidade foi avaliada pelo acompanhamento dos sinais vitais e resultados de exames laboratoriais, por consultas e por relato espontâneo dos voluntarios. ICs 90% para Cmax, AUC0-t e AUC0-inf foram 92.1% - 108.2%, 90.7% - 98.0%, e 94.8% - 100.0%, respectivamente. Os eventos adversos observados foram nausea e cefaleia. Concluiu-se que os produtos Tavanic(c) e Levaquin(c) sao bioequivalentes, uma vez que os ICs 90% estao dentro da faixa de 80%-125% proposta pelas agencias reguladoras

Azelastine hydrochloride and budesonide (nasal sprays): effectiveness combination therapy monitored by acoustic rhinometry and clinical symptom score in the treatment of allergic rhinitis

Methods The study population consisted of 28 patients (9 female and 19 males, aged between 18-32 years) with diagnostic of persistent AR (ARIA consensus). This was a randomized, crossover study. Subjects were randomly assigned to receive either azelastine hydrochloride (140 mcg/nostril) or budesonide (64mcg/nostril) or both drugs. All patients received the three treatments using nasal spray twice daily, each period of treatment lasted 30 days and washout period was 7 days. Subjects were submitted to nasal provocation test (NPT) with histamine before and after each period of treatment. Nasal responsiveness to histamine was monitored based on subjective (symptom score) and objective parameters (acoustic rhinometry) to compare the treatments. After acoustic rhinometry measure (baseline) histamine was instilled in nasal cavity (0.5mg/mL/nostril) via nasal spray. Minimal cross-area (MCA2) was measured by acoustic rhinometry at times 1; 4; 8; and 12 minutes after NPT for each histamine concentration (0.5; 1; 2; 4 and 6 mg/mL) up to positive response occurs (nasal obstruction). The criteria for a positive response were histamine dose and rhinometric measure time causing at least 20% fall in MCA2 (NPT20). NPT was stopped when a positive response occurred. Statistical significance was assessed by paired t-test.