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

NCT01327261 | Completed Phase 4 DMC

• 1 other identifier: Phoenix-Evoser (PHOE 1-0903)
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Keywords

levodopa; benserazide; bioequivalence; pharmacokinetics; A Single - Dose; Randomized- Sequence; Open -Label Crossover Study

Outcome Measures

Primary Outcomes (1)

• Comparison of Area Under the Curve and Peak Concentration of plasma levodopa reached after two different drug products containing levodopa + benserazide

  In order to comply with Argentine regulation for marketing approval this study includes 24 healthy volunteers to investigate whether the relative bioavailability of the test formulation met the regulatory criterion for the assumption of bioequivalence to the branded formulation. After dosing with each formulation, 17 blood samples are taken to measure plasma levodopa concentration by HPLC. With plasma concentration values, pharmacokinetic parameters are calculated and bioequivalence assessed with WinNonLin software.

  Blood samples are collected up to 6 hours after dosing. (day 1)

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety

  Clinical evaluation are performed up to 6 hours after dosing. (day 1)

Study Arms (2)

Levodopa + benserazide (test formulation)

EXPERIMENTAL

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

Drug: Levodopa + benserazide

Levodopa + benserazide (reference formulation)

ACTIVE COMPARATOR

Drug: Levodopa + benserazide

Interventions

Levodopa + benserazide DRUG

Single oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water.

Levodopa + benserazide (reference formulation); Levodopa + benserazide (test formulation)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Buenos Aires: lead
• Laboratorios Phoenix S.A.I.C.y F.: collaborator

Related Publications (1)

• 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.

  PMID: 21635995 DERIVED

MeSH Terms

Interventions

benserazide, levodopa drug combination

Study Officials

• Guillermo Di Girolamo, MD, PhD

  Buenos Aires University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: April 1, 2011
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 4, 2011

Record last verified: 2011-03