ABSTRACT
This paper deals with a crossover trial on healthy volunteers performed to obtain combined pharmacodynamic, safety and pharmacokinetic data in order to assess the bioequivalence of formoterol fumarate (CAS 43229-80-7) delivered by mono-dose dry powder inhalers, as test and reference. The trial was carried out on 24 Caucasian healthy male and female volunteers treated with 12 micrograms formoterol fumarate bihydrate capsules for inhalation route. Pharmacodynamics was evaluated through a challenge test with methacholine on the forced expiratory volume in 1 s (FEV1). Safety was achieved from glucose and potassium serum levels assayed on timed samples over a 12-h period cost-dosing and from blood pressure, heart rate and ECG recording. Pharmacokinetics was obtained from urinary excretion of formoterol, assessed by a highly sensitive analytical method (LC-MS-MS). Pharmacodynamic, safety and pharmacokinetic results evidenced the bioequivalence of the two formulations investigated. This investigation is an interesting approach how to assess bioequivalence when the classical approach based on the similarity of plasma concentrations can not be applied.
Subject(s)
Adrenergic beta-Agonists/administration & dosage , Adrenergic beta-Agonists/pharmacokinetics , Anti-Asthmatic Agents/administration & dosage , Anti-Asthmatic Agents/pharmacokinetics , Ethanolamines/administration & dosage , Ethanolamines/pharmacokinetics , Administration, Inhalation , Adrenergic beta-Agonists/urine , Adult , Anti-Asthmatic Agents/urine , Blood Glucose/metabolism , Electrocardiography/drug effects , Ethanolamines/urine , Female , Forced Expiratory Volume/drug effects , Formoterol Fumarate , Humans , Male , Potassium/blood , Therapeutic Equivalency , Vital Capacity/drug effectsABSTRACT
Malignant pleural effusions due to multiple myeloma are rare. Effusion in such patients is usually due to congestive heart failure or another process. Malignant myeloma cells identified in cytologic examination of the pleural fluid or by pleural biopsy establish the diagnosis of a myelomatous effusion. This finding portends a poor prognosis and death usually within 4 months.
