Comparative assessment of the absorption of a generic formulation of Inhaled Insulin against the innovators Humalog KwikPen for injection and the AFREZZA Inhalation Powder Cartridge conducted under fasting conditions in healthy male and female volunteers

Single dose, crossover study design whereby each participant receives the inhaled insulin (test) on one occasion and the innovator formulations of Humalog KwikPen (reference 1) on one occasion and Inhalation Powder cartridge (reference 2) on one occassion with each dose separated by a washout period of at least 2 days. The intervention for this trial is the test formulation of inhaled insulin. Subject are allowed to sip water throughout each study period but are required not to eat for 10 hours before receiving each dose and to fast for approximately 8 hours after each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for 8 hours after dosing. Each subject will receive a standard meal at about 8 hours after dosing in each study period with no additional food intake allowed. Alcohol breath testing, cotinine urine testing and checking of the subjects inhalation technique will be performed upon each participant reporting to the Clinical Site at least 12 hours prior to dosing. Pre and post study laboratory, chest X-Ray, ECG, oximetry and spirometry tests will be completed to assess the health of participants along with HIV, Hepatitis, serum pregnancy, RPR and drugs of abuse testing. The test and reference 2 dose will be inhaled using an inhaler. Each subject will be trained on the correct use of the inhaler using empty training devices. To monitor glucose levels a glucose clamp technique will be employed to reduce the risk of hypoglycemia. Due to the commercially sensitive nature of this study the Sponsor Company has requested that the doses to be administered are not disclosed.