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

Healthy Volunteers Clinical Trial

— PHOE10903  

Official title:

Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers: A Single- Dose Randomized- Sequence, Open -Label Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327261
• Other study ID #: Phoenix-Evoser (PHOE 1-0903)
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2011
• Last updated: August 3, 2011
• Start date: August 2009
• Est. completion date: December 2009

Study information

• Verified date: March 2011
• Source: University of Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Buenos Aires	Laboratorios Phoenix S.A.I.C.y F.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Number of Participants with Adverse Events as a Measure of Safety	Volunteers are asked about any discomfort or unusual manifestation they feel. Vital signs are recorded at each sampling time.	Clinical evaluation are performed up to 6 hours after dosing. (day 1)	Yes