Parkinson's disease ziekte van Parkinson
Conditions
Interventions
First visit: inhalation of 30 mg levodopa inhalation powder.
Second visit: inhalation of 60 mg levodopa inhalation powder.
Third visit: regular oral levodopa medication.
During all three visits, t
Sponsors
Department of Pharmaceutical Technology and Biopharmacy, Faculty of Mathematics and Natural Sciences, University of Groningen
Eligibility
Inclusion criteria
Inclusion criteria: Signed informed consent. Diagnosed with Parkinson’s disease At least 18 years old. Currently on stable Parkinson’s disease levodopa regimen. Require levodopa containing medication regimen with a maximum of 4 administrations a day. Able to perform spirometry
Exclusion criteria
Exclusion criteria: Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent. Pregnant or breast feeding. Active pulmonary disease. Patients with known symptomatic orthostatic hypotension. The use of COMT inhibitors and/or MAO-B inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum levodopa concentration in plasma(Cmax). Time to maximum concentration (Tmax). Area under the concentration time (minutes) curve at 0-180 min (AUC0-180) after administration of the dose (related to the actual dose administered, weighed dose minus remained dose in inhaler after inhalation). | — |
Secondary
| Measure | Time frame |
|---|---|
| Absorption rate constant (Ka) of levodopa after pulmonary administration. Terminal elimination half life (T1/2el) of levodopa after pulmonary administration. Decrease of FEV1 in percentage measured by spirometry (at predose, 35 and 100 minutes after administration. Number of participants with adverse events (both spontaneously reported and reported as a result of questioning by the researcher. | — |
Contacts
Public ContactM. Luinstra
RVE klinische farmacie Van Swietenplein 1 Postbus 30033
Outcome results
None listed