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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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
 Drug: Levodopa + benserazide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers: A Single- Dose Randomized- Sequence, Open -Label Crossover Study

Resource links provided by NLM:

Drug Information available for: Levodopa
U.S. FDA Resources

Further study details as provided by University of Buenos Aires:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 24
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Levodopa + benserazide
Single oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water.
Active Comparator: Levodopa + benserazide (reference formulation) Drug: Levodopa + benserazide
Single oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327261

Sponsors and Collaborators
University of Buenos Aires
Laboratorios Phoenix S.A.I.C.y F.
Investigators
Principal Investigator: Guillermo Di Girolamo, MD, PhD Buenos Aires University
  More Information

No publications provided by University of Buenos Aires

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Guillermo Di Girolamo, Buenos Aires University
ClinicalTrials.gov Identifier: NCT01327261     History of Changes
Other Study ID Numbers: Phoenix-Evoser (PHOE 1-0903)
Study First Received: March 28, 2011
Last Updated: August 3, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by University of Buenos Aires:
levodopa
benserazide
bioequivalence
pharmacokinetics
 A Single - Dose
Randomized- Sequence
Open -Label Crossover Study

Additional relevant MeSH terms:
Benserazide
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013