Comparative assessment of the absorption of a single oral dose of ipratropium bromide in healthy male and female volunteers with and without concurrent oral charcoal blockade.

Single dose, crossover study design whereby each participant receives the formulation of ipratropium bromide (1 x 500 mcg) on one occasion with oral charcoal administered pre-dose and at specified times up to 4 hours post dosing and on one occasion without oral charcoal with each dose separated by a one week washout period. The intervention for this trial is ipratropium bromide with charcoal. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose). Participants are required not to eat for 10 hours before receiving each dose and to fast for approximately 4 hours after receiving 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. Vital sign examination, assessment of well-being, alcohol breath testing, drug testing and pregnancy testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the healthy of participants along with HIV, Hepatitis and drugs of abuse testing. The volunteer's randomsied to receive 50 ml of activated charcoal suspension will be given the charcoal suspension 2 minutes prior to dosing, immediately with dosing and also at 1, 2 and 4 hours post dosing. Each dose (1 x 500 mcg) will be taken orally as 2 ml of ipratropium bromide solution in 18 ml of water. Medication will be administered via a 30 ml syringe and a mouth check will be conducted to ensure the medication has been taken as directed.