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Pharmacokinetic Profile of a Generic Formulation of Sofosbuvir and Its Metabolite GS-331007 in Healthy Chinese Subjects.
Shen, Zhenwei; Zhu, Xiaoxue; Zhang, Hong; Chen, Hong; Niu, Junqi; Chen, Guiling; Li, Xiaojiao; Ding, Yanhua.
Afiliación
  • Shen Z; Institute of Immunology, Academy of Translational Medicine, The First Hospital of Jilin University, Jilin University, Changchun, People's Republic of China.
  • Zhu X; Phase I Clinical Trial Unit, China-Frontage USA, The First Hospital of Jilin University, Jilin University, Changchun, People's Republic of China.
  • Zhang H; Phase I Clinical Trial Unit, China-Frontage USA, The First Hospital of Jilin University, Jilin University, Changchun, People's Republic of China.
  • Chen H; Phase I Clinical Trial Unit, China-Frontage USA, The First Hospital of Jilin University, Jilin University, Changchun, People's Republic of China.
  • Niu J; Phase I Clinical Trial Unit, China-Frontage USA, The First Hospital of Jilin University, Jilin University, Changchun, People's Republic of China.
  • Chen G; Phase I Clinical Trial Unit, China-Frontage USA, The First Hospital of Jilin University, Jilin University, Changchun, People's Republic of China.
  • Li X; Phase I Clinical Trial Unit, China-Frontage USA, The First Hospital of Jilin University, Jilin University, Changchun, People's Republic of China.
  • Ding Y; Phase I Clinical Trial Unit, China-Frontage USA, The First Hospital of Jilin University, Jilin University, Changchun, People's Republic of China.
Clin Pharmacol Drug Dev ; 8(8): 1073-1080, 2019 11.
Article en En | MEDLINE | ID: mdl-30900816
Sofosbuvir is an NS5B nucleotide inhibitor for the treatment of hepatitis C viral infection. In this study the pharmacokinetics (PK) and safety of single and multiple doses of generic sofosbuvir were investigated in healthy Chinese subjects. Twelve subjects (6 male and 6 female) were enrolled in this study. The PK parameters of sofosbuvir and its metabolite (GS-331007) in both blood and urine samples were analyzed after dosing by the established liquid chromatography tandem mass spectrometry analytical method. The safety/tolerability assessment consisted of documenting adverse events, vital signs, electrocardiogram, and laboratory test results. Sofosbuvir was well tolerated. Major PK parameters of the generic formulation of sofosbuvir were similar to those found in previous reports. These data support further clinical evaluation of this generic formulation of sofosbuvir.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Uridina / Medicamentos Genéricos / Sofosbuvir Tipo de estudio: Prognostic_studies Límite: Adult / Female / Humans / Male Idioma: En Revista: Clin Pharmacol Drug Dev Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Uridina / Medicamentos Genéricos / Sofosbuvir Tipo de estudio: Prognostic_studies Límite: Adult / Female / Humans / Male Idioma: En Revista: Clin Pharmacol Drug Dev Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos