Inhaled micronized crystalline human insulin using a dry powder inhaler: dose-response and time-action profiles1

Autor: Douglas B. Muchmore, Leszek Nosek, J. Chien, C. S. Ernest, C. Gonzales, Lutz Heinemann, Klaus Rave
Rok vydání: 2004
Předmět:
Zdroj: Diabetic Medicine. 21:763-768
ISSN: 0742-3071
DOI: 10.1111/j.1464-5491.2004.01240.x
Popis: Aim The aim of this euglycaemic glucose clamp study was to investigate the pharmacokinetics, glucodynamics, safety and tolerability of micronized crystalline human insulin inhalation powder delivered by a Spiros® dry powder inhaler system in healthy volunteers. Methods Thirteen healthy, non-smoking, male and female volunteers [age 30 ± 7 years; BMI 23.5 ± 2.7 kg/m2; (mean ± sd)] with normal pulmonary function participated in an open-label, randomised, 6-period crossover trial. Each volunteer received four single doses of inhaled insulin (60, 90, 120, 150 U) on separate occasions. For comparison, each volunteer also received two of three possible doses of subcutaneous (s.c.) injected regular human insulin (8, 14, or 20 U). Results Serum immunoreactive insulin following inhalation of insulin peaked an average of 60 min earlier compared with s.c. injected insulin (P
Databáze: OpenAIRE