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

NCT ID: NCT01327261

Last Updated: 2011-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2009-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Levodopa + benserazide

Intervention Type: 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)

Group Type: ACTIVE_COMPARATOR

Levodopa + benserazide

Intervention Type: DRUG

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

Interventions

Levodopa + benserazide

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratorios Phoenix S.A.I.C.y F.

UNKNOWN

Sponsor Role: collaborator

University of Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

Buenos Aires University

Principal Investigators

Guillermo Di Girolamo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Buenos Aires University

References

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.

Reference Type: DERIVED

PMID: 21635995 (View on PubMed)

Other Identifiers

Phoenix-Evoser (PHOE 1-0903)

Identifier Type: -

Identifier Source: org_study_id