Clinical trial NCT01327261: Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers
Official title: Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers: A Single- Dose Randomized- Sequence, Open -Label Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Keywords: levodopa
benserazide
bioequivalence
pharmacokinetics
A Single - Dose
Randomized- Sequence
Open -Label Crossover Study
Lead sponsor: University of Buenos Aires
Sponsor class: OTHER
Collaborators: name: Laboratorios Phoenix S.A.I.C.y F.
First posted: 2011-04-01
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of Area Under the Curve and Peak Concentration of plasma levodopa reached after two different drug products containing levodopa + benserazide
timeFrame: Blood samples are collected up to 6 hours after dosing. (day 1)
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: Clinical evaluation are performed up to 6 hours after dosing. (day 1)
Other outcomes:
Locations:
Study officials:
affiliation: Buenos Aires University
name: Guillermo Di Girolamo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.