Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers

Phase 4 Completed 24 enrolled University of Buenos Aires Laboratorios Phoenix S.A.I.C.y F. · collab

RandomizedCrossoverOpen-label

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.

Timeline

Start: 2009-08
Primary completion: 2009-10
Completion: 2009-12

Outcome

Met primary endpoint

paper In this single-dose study, the test formulation of levodopa/benserazide tablets met the Argentinean criterion for bioequivalence to the reference formulation. PMID 21635995 ↗

Publications

Keller GA, Czerniuk P, Bertuola R, Spatz JG, Assefi AR, Di Girolamo G. Comparative bioavailability of 2 tablet formulations of levodopa/benserazide in healthy, fasting volunteers: a single-dose, randomized-sequence, open-label crossover study. Clin Ther. 2011 Apr;33(4):500-10. doi: 10.1016/j.clinthera.2011.04.012.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levodopa	Unknown	200 mg	Oral
Subject	benserazide	Small molecule	50 mg	Oral

Indications

No indication recorded.