IPHARMA was authorized to conduct 2 clinical trials

IPHARMA obtained two clinical trial authorizations issued by the Ministry of Healthcare of the Russian Federation to conduct clinical trials of NovaMedica Innotech Ltd. products.


Protocol № CNS-MEM-01 "An open-label randomized clinical study of safety and comparative pharmakokinetics of a fixed combined drug MEMORIA (Memantin + Citicoline) in modified-release tablets with film coating, 5 mg + 500 mg / 10 mg + 500 mg (NovaMedica Innotech Ltd., Russia), and the drugs Akatinol Memantine in tablets with film coating, 5 mg / 10 mg (Rottendorf Pharma GmbH, Germany) and Ceraxon® a solution for oral administration, 100 mg / ml (Grupo Ferrer Internacional, S.A., Spain) after single dosing in cross-over groups and multiple dosing in parallel groups in healthy volunteers, including an assessment of the food-effect and drug-drug interactions".


The purpose is to assess safety and study comparative pharmakokinetics of a fixed combined drug MEMORIA (Memantin + Citicoline) in modified-release tablets with film coating, 5 mg + 500 mg / 10 mg + 500 mg (NovaMedica Innotech Ltd., Russia), and the drugs Akatinol Memantine in tablets with film coating, 5 mg / 10 mg (Rottendorf Pharma GmbH, Germany) and Ceraxon® a solution for oral administration, 100 mg / ml (Grupo Ferrer Internacional, S.A., Spain) in healthy volunteers.


Protocol № CNS-GAB-01 "An open-label randomized clinical study of safety and comparative pharmakokinetics of a fixed combined drug GABBIE (Gabapentin + Benfotiamine) in extended-release tablets with film coating, 300 mg + 100 mg / 600 mg + 100 mg (NovaMedica Innotech Ltd., Russia), and the drugs Neurontin® and Benfogamma® after single dosing in cross-over groups and multiple dosing in parallel groups in healthy volunteers, including an assessment of the food-effect".


The purpose is to assess safety and study comparative pharmakokinetics of a fixed combined drug GABBIE (Gabapentin + Benfotiamine) in extended-release tablets with film coating, 300 mg + 100 mg / 600 mg + 100 mg (NovaMedica Innotech Ltd., Russia), and the drugs Neurontin® and Benfogamma® in healthy volunteers.

Недавние посты
Архив

© 2021 IPHARMA

  • Facebook Social Icon
  • LinkedIn Social Icon
  • YouTube Social  Icon
  • Instagram Social Icon