Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers (PHOE10903)

University of Buenos Aires

Status and phase: Completed; Phase 4

Conditions: Healthy Volunteers

Treatments: Drug: Levodopa + benserazide

Study type: Interventional

Funder types: Other

Identifiers

NCT01327261

Phoenix-Evoser (PHOE 1-0903)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Caucasian Argentinean males and females volunteers aged 21 to 50 years with a body mass index from 19 to 27 kg/m2 were enrolled in this study.
• All volunteers provided written informed consent prior to study initiation.

Exclusion criteria

• History of cardiovascular, hepatic, renal, psychiatric, neurologic, hematologic, or metabolic disease
• Drug or alcohol abuse within 2 years before the start of the study
• Smoking
• HIV, hepatitis B, or hepatitis C infection
• Consumption of any prescribed or over-the-counter drug within 2 weeks before the study or
• Participation in a similar study within the past 6 months. Female subjects were not to be pregnant, planning to become pregnant, or breastfeeding at the time of the study, and were required to use an effective method of contraception (intrauterine device or hormonal method) throughout the study.

Trial design

24 participants in 2 patient groups

Levodopa + benserazide (test formulation)

Experimental group

Description:

A randomized-sequence, open-label, 2-period crossover study assessing relative bioavailability of two drug products containing the association levodopa + benserazide.

Treatment:

Drug: Levodopa + benserazide

Levodopa + benserazide (reference formulation)

Active Comparator group

Treatment:

Drug: Levodopa + benserazide