Study to investigate the effect of an inhibition of the renal cationic drug transporter on single dose pharmacokinetics of intravenous tiotropium in subjects in an age close to typical Chronic Obstructive Pulmonary Disease (COPD) population
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Cmax of plasma levels of tiotropium after dosing
Time frame: up to 8 hours after i.v. treatment
Area under the curve (AUC) 0-4h of the plasma levels of tiotropium after dosing
Time frame: 0 - 4 hours after i.v. treatment
Urinary excretion 0-4h after dosing (Ae0-4h)
Time frame: 0 - 4 hours after i.v. treatment
Renal clearance of tiotropium (CLR)
Time frame: pre-dose, 0-4 h, 4-8 h, 8-12 h, 12-24 , 24-28 h, 38-72 h and 72-96 h after i.v. treatment
AUC 0-8h of plasma levels of tiotropium after dosing
Time frame: 0-8 hours after treatment
Urinary excretion 0-96h after dosing (Ae0-96h)
Time frame: 0-96 hours after treatment
Occurrence of Adverse Events
Time frame: up to 4 - 8 days after last i.v. treatment
Changes from baseline in Laboratory Tests
Time frame: Baseline, 4 - 8 days after last i.v. treatment
Changes in 12-lead electrocardiogram (ECG)
Time frame: up to 24 h after i.v. treatment
Changes in Blood Pressure and Pulse Rate
Time frame: up to 4 - 8 days after last i.v. treatment
Changes from baseline in physical examination
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Time frame: Baseline, 4 - 8 days after last i.v. treatment