Healthy Volunteers
Conditions
Keywords
levodopa, benserazide, bioequivalence, pharmacokinetics, A Single - Dose, Randomized- Sequence, Open -Label Crossover Study
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.
Interventions
DRUGLevodopa + benserazide
Single oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water.
Sponsors
Laboratorios Phoenix S.A.I.C.y F.
University of Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Area Under the Curve and Peak Concentration of plasma levodopa reached after two different drug products containing levodopa + benserazide | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety | 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. |
Outcome results
None listed