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[Pharmacokinetic comparison of Sinemet and Grifoparkin (levodopa/carbidopa 250/25 mg) in Parkinson s disease: a single dose study]. / Comparación farmacocinética de Sinemet y Grifoparkin (levodopa/carbidopa 250/25 mg) en pacientes con enfermedad de Parkinson avanzada: un estudio con dosis única.
Chaná, Pedro; Fierro, Angélica; Reyes-Parada, Miguel; Sáez-Briones, Patricio.
Afiliação
  • Chaná P; Unidad de Movimientos Anormales, Servicio de Neurología y Neurocirugía, Hospital DIPRECA. pedrochana@mi.cl
Rev Med Chil ; 131(6): 623-31, 2003 Jun.
Article em Es | MEDLINE | ID: mdl-12942590
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 and Grifoparkin (generic carbidopa/levodopa 250/25 mg) in patients with advanced Parkinson's disease. PATIENTS AND METHODS: Patients were randomly assigned to Sinemet (15 patients 62 +/- 12 years old; mean disease duration 11 +/- 7 years) or Grifoparkin (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 or Grifoparkin, 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 and Grifoparkin respectively (NS). Cmax (maximal L-DOPA concentration reached) was 3161 +/- 345 ng/ml for Sinemet and 3274 +/- 520 ng/ml for Grifoparkin (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 and 161 +/- 48 min, 58.7 +/- 8 l/h and 3.0 +/- 0.7 l/kg for Grifoparkin (NS). UPDRS-III value for the best "on state" and for the worst "off state" were 23 +/- 11 and 50 +/- 19 for Sinemet and 20 +/- 7 and 46 +/- 13 for Grifoparkin respectively (NS). CONCLUSION: The results obtained showed that both drugs are bioequivalent in patients with advanced Parkinson's disease.
Assuntos
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Doença de Parkinson / Carbidopa / Levodopa / Antiparkinsonianos Tipo de estudo: Clinical_trials Limite: Female / Humans / Male / Middle aged Idioma: Es Revista: Rev Med Chil Ano de publicação: 2003 Tipo de documento: Article País de publicação: Chile
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Doença de Parkinson / Carbidopa / Levodopa / Antiparkinsonianos Tipo de estudo: Clinical_trials Limite: Female / Humans / Male / Middle aged Idioma: Es Revista: Rev Med Chil Ano de publicação: 2003 Tipo de documento: Article País de publicação: Chile