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

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.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levodopa + benserazide

Drug

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

Primary outcomes

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)

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 outcomes

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)

Volunteers are asked about any discomfort or unusual manifestation they feel. Vital signs are recorded at each sampling time.

Sponsors and collaborators

Lead sponsor

University of Buenos Aires

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PHOE10903

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Apr 1, 2011
Registry last updated: Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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