Comparación farmacocinética de Sinemetây Grifoparkinâ (levodopa/carbidopa 250/25 mg) en pacientes con enfermedad de Parkinson avanzada: un estudio con dosis única

Background: There are doubts wether generic medications have the same bioavailability and efficacy compared with the original drugs developed by pharmaceutical companies with research capabilities. Aim: To compare the pharmacokinetics and clinical (motor) responses of Sinemet<FONT FACE=Symbol>...

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Autores principales:	Chaná C,Pedro, Fierro H,Angélica, Reyes-Parada,Miguel, Sáez-Briones,Patricio
Lenguaje:	Spanish / Castilian
Publicado:	Sociedad Médica de Santiago 2003
Materias:	Antiparkinson agents Carbidopa Levodopa Pharmacokinetics Parkinson's disease
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872003000600006
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spelling	oai:scielo:S0034-988720030006000062004-12-13Comparación farmacocinética de Sinemetây Grifoparkinâ (levodopa/carbidopa 250/25 mg) en pacientes con enfermedad de Parkinson avanzada: un estudio con dosis únicaChaná C,PedroFierro H,AngélicaReyes-Parada,MiguelSáez-Briones,Patricio Antiparkinson agents Carbidopa Levodopa Pharmacokinetics Parkinson's disease Background: There are doubts wether generic medications have the same bioavailability and efficacy compared with the original drugs developed by pharmaceutical companies with research capabilities. Aim: To compare the pharmacokinetics and clinical (motor) responses of Sinemet<FONT FACE=Symbol>â</FONT> and Grifoparkin<FONT FACE=Symbol>â</FONT>(generic carbidopa/levodopa 250/25 mg) in patients with advanced Parkinson's disease. Patients and methods: Patients were randomly assigned to Sinemet<FONT FACE=Symbol>â</FONT> (15 patients 62±12 years old; mean disease duration 11±7 years) or Grifoparkin<FONT FACE=Symbol>â</FONT> (15 patients, 64±11 years old; mean disease duration 12±4 years) groups. Medication and food were withheld 12 h before the study. Fifteen blood samples were collected (starting 9 AM) immediately before (sample 1, t=0 min) and after (samples 2-15, t=20-360 min) oral administration of a single dose of Sinemet<FONT FACE=Symbol>â</FONT> or Grifoparkin<FONT FACE=Symbol>â</FONT>, and plasmatic L-DOPA was quantified using HPLC with electrochemical detection. Additionally, each patient was clinically evaluated every 20 minutes, using the tapping test and the unified Parkinson's disease scale Hoehn & Yarh. Results: Tmax (time at which the maximal L-DOPA concentration was reached) were 69±12 min and 64±11 min for Sinemet<FONT FACE=Symbol>â</FONT> and Grifoparkin<FONT FACE=Symbol>â</FONT> respectively (NS). Cmax (maximal L-DOPA concentration reached) was 3161±345 ng/ml for Sinemet<FONT FACE=Symbol>â</FONT> and 3274±520 ng/ml for Grifoparkin<FONT FACE=Symbol>â</FONT> (NS). The t1/2 (half life time), CL (clearance) and volume of distribution (Vd) values calculated were 159±32 min, 51.7±5.1 1/h and 3.6±1.2 l/kg for Sinemet<FONT FACE=Symbol>â</FONT> and 161±48 min, 58.7±8 l/h and 3.0±0.7 l/kg for Grifoparkin<FONT FACE=Symbol>â</FONT> (NS). UPDRS-III value for the best "on state" and for the worst "off state" were 23±11 and 50±19 for Sinemet<FONT FACE=Symbol>â</FONT> and 20±7 and 46±13 for Grifoparkin<FONT FACE=Symbol>â</FONT> respectively (NS). Conclusion: the results obtained showed that both drugs are bioequivalent in patients with advanced Parkinson's disease (Rev Méd Chile 2003; 131: 623-631)info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.131 n.6 20032003-06-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872003000600006es10.4067/S0034-98872003000600006
institution	Scielo Chile
collection	Scielo Chile
language	Spanish / Castilian
topic	Antiparkinson agents Carbidopa Levodopa Pharmacokinetics Parkinson's disease
spellingShingle	Antiparkinson agents Carbidopa Levodopa Pharmacokinetics Parkinson's disease Chaná C,Pedro Fierro H,Angélica Reyes-Parada,Miguel Sáez-Briones,Patricio Comparación farmacocinética de Sinemetây Grifoparkinâ (levodopa/carbidopa 250/25 mg) en pacientes con enfermedad de Parkinson avanzada: un estudio con dosis única
description	Background: There are doubts wether generic medications have the same bioavailability and efficacy compared with the original drugs developed by pharmaceutical companies with research capabilities. Aim: To compare the pharmacokinetics and clinical (motor) responses of Sinemet<FONT FACE=Symbol>â</FONT> and Grifoparkin<FONT FACE=Symbol>â</FONT>(generic carbidopa/levodopa 250/25 mg) in patients with advanced Parkinson's disease. Patients and methods: Patients were randomly assigned to Sinemet<FONT FACE=Symbol>â</FONT> (15 patients 62±12 years old; mean disease duration 11±7 years) or Grifoparkin<FONT FACE=Symbol>â</FONT> (15 patients, 64±11 years old; mean disease duration 12±4 years) groups. Medication and food were withheld 12 h before the study. Fifteen blood samples were collected (starting 9 AM) immediately before (sample 1, t=0 min) and after (samples 2-15, t=20-360 min) oral administration of a single dose of Sinemet<FONT FACE=Symbol>â</FONT> or Grifoparkin<FONT FACE=Symbol>â</FONT>, and plasmatic L-DOPA was quantified using HPLC with electrochemical detection. Additionally, each patient was clinically evaluated every 20 minutes, using the tapping test and the unified Parkinson's disease scale Hoehn & Yarh. Results: Tmax (time at which the maximal L-DOPA concentration was reached) were 69±12 min and 64±11 min for Sinemet<FONT FACE=Symbol>â</FONT> and Grifoparkin<FONT FACE=Symbol>â</FONT> respectively (NS). Cmax (maximal L-DOPA concentration reached) was 3161±345 ng/ml for Sinemet<FONT FACE=Symbol>â</FONT> and 3274±520 ng/ml for Grifoparkin<FONT FACE=Symbol>â</FONT> (NS). The t1/2 (half life time), CL (clearance) and volume of distribution (Vd) values calculated were 159±32 min, 51.7±5.1 1/h and 3.6±1.2 l/kg for Sinemet<FONT FACE=Symbol>â</FONT> and 161±48 min, 58.7±8 l/h and 3.0±0.7 l/kg for Grifoparkin<FONT FACE=Symbol>â</FONT> (NS). UPDRS-III value for the best "on state" and for the worst "off state" were 23±11 and 50±19 for Sinemet<FONT FACE=Symbol>â</FONT> and 20±7 and 46±13 for Grifoparkin<FONT FACE=Symbol>â</FONT> respectively (NS). Conclusion: the results obtained showed that both drugs are bioequivalent in patients with advanced Parkinson's disease (Rev Méd Chile 2003; 131: 623-631)
author	Chaná C,Pedro Fierro H,Angélica Reyes-Parada,Miguel Sáez-Briones,Patricio
author_facet	Chaná C,Pedro Fierro H,Angélica Reyes-Parada,Miguel Sáez-Briones,Patricio
author_sort	Chaná C,Pedro
title	Comparación farmacocinética de Sinemetây Grifoparkinâ (levodopa/carbidopa 250/25 mg) en pacientes con enfermedad de Parkinson avanzada: un estudio con dosis única
title_short	Comparación farmacocinética de Sinemetây Grifoparkinâ (levodopa/carbidopa 250/25 mg) en pacientes con enfermedad de Parkinson avanzada: un estudio con dosis única
title_full	Comparación farmacocinética de Sinemetây Grifoparkinâ (levodopa/carbidopa 250/25 mg) en pacientes con enfermedad de Parkinson avanzada: un estudio con dosis única
title_fullStr	Comparación farmacocinética de Sinemetây Grifoparkinâ (levodopa/carbidopa 250/25 mg) en pacientes con enfermedad de Parkinson avanzada: un estudio con dosis única
title_full_unstemmed	Comparación farmacocinética de Sinemetây Grifoparkinâ (levodopa/carbidopa 250/25 mg) en pacientes con enfermedad de Parkinson avanzada: un estudio con dosis única
title_sort	comparación farmacocinética de sinemetây grifoparkinâ (levodopa/carbidopa 250/25 mg) en pacientes con enfermedad de parkinson avanzada: un estudio con dosis única
publisher	Sociedad Médica de Santiago
publishDate	2003
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872003000600006
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Comparación farmacocinética de Sinemetây Grifoparkinâ (levodopa/carbidopa 250/25 mg) en pacientes con enfermedad de Parkinson avanzada: un estudio con dosis única

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