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

This study has been completed.
Sponsor:
Collaborator:
Laboratorios Phoenix S.A.I.C.y F.
Information provided by:
University of Buenos Aires
ClinicalTrials.gov Identifier:
NCT01327261
First received: March 28, 2011
Last updated: August 3, 2011
Last verified: March 2011
History of Changes

March 28, 2011
August 3, 2011
August 2009
October 2009   (final data collection date for primary outcome measure)
Comparison of Area Under the Curve and Peak Concentration of plasma levodopa reached after two different drug products containing levodopa + benserazide [ Time Frame: Blood samples are collected up to 6 hours after dosing. (day 1) ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01327261 on ClinicalTrials.gov Archive Site
Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: Clinical evaluation are performed up to 6 hours after dosing. (day 1) ] [ Designated as safety issue: Yes ]
Volunteers are asked about any discomfort or unusual manifestation they feel. Vital signs are recorded at each sampling time.
Same as current
Not Provided
Not Provided
 
Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers
Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers: A Single- Dose Randomized- Sequence, Open -Label Crossover Study

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteers
Drug: Levodopa + benserazide
Single oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water.
  • Experimental: Levodopa + benserazide (test formulation)
    A randomized-sequence, open-label, 2-period crossover study assessing relative bioavailability of two drug products containing the association levodopa + benserazide.
    Intervention: Drug: Levodopa + benserazide
  • Active Comparator: Levodopa + benserazide (reference formulation)
    Intervention: Drug: Levodopa + benserazide
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01327261
Phoenix-Evoser (PHOE 1-0903)
Yes
Guillermo Di Girolamo, Buenos Aires University
University of Buenos Aires
Laboratorios Phoenix S.A.I.C.y F.
Principal Investigator: Guillermo Di Girolamo, MD, PhD Buenos Aires University
University of Buenos Aires
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP