Comparative assessment of the absorption of a generic formulation of tiotropium test product 1 and tiotropium test product 2 against the innovator Spiriva HandiHaler conducted under fasting conditions in healthy male and female volunteers

Single dose, crossover study design whereby each participant receives tiotropium test formulation 1 on one occasion, tiotropium test formulation 2 on one occasion and the innovator formulation of Spiriva HandiHaler on one occasion with each dose separated by a 21 day washout period. The intervention for this trial is the test formulation of tiotropium. No water is allowed for 1 hour prior to dosing until 2 hours after dosing. Participants are required not to eat for 10 hours before receiving each dose and to fast for approximately 4 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 and for 24 hours after dosing. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing , urine dipstick pregnancy testing and urine dipstick drugs of abuse testing will be performed upon each participant reporting to the Clinical Site at least 10 hours prior to dosing. Pre and post study laboratory, 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. Each dose will be inhaled using an inhaler. Each subject will be trained on the correct use of the inhaler using empty training devices. Due to the commercially sensitive nature of this study the Sponsor company has requested that the doses to be administered are not disclosed.