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| Name | Class |
|---|---|
| Laboratorios Phoenix S.A.I.C.y F. | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levodopa + benserazide (test formulation) | Experimental | A randomized-sequence, open-label, 2-period crossover study assessing relative bioavailability of two drug products containing the association levodopa + benserazide. |
|
| Levodopa + benserazide (reference formulation) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levodopa + benserazide | Drug | Single oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Di Girolamo, MD, PhD | Buenos Aires University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21635995 | Derived | 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. |
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| ID | Term |
|---|---|
| C005177 | benserazide, levodopa drug combination |
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