Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
A group of 24 healthy volunteers receive one tablet of an association of levodopa 200 mg and
benserazide 50 mg corresponding to two drug products: a test formulation (Evoser ®; Phoenix
S.A.I.C. y F., Buenos Aires, Argentina) and a reference formulation (Madopar ®; Roche Pharma,
Switzerland) to assess their relative bioavailability. After administration of each
formulation 17 blood samples are taken and levodopa is measured by HPLC. Pharmacokinetic
parameters (AUC, Tmax and Cmax) are compared.