GEL FORM SAFETY AND TOLERABILITY STUDY OF RECOMBINANT HUMAN ANGIOGENIN UNDER TRADE NAME "FARMAGEN" FOR APPLICATION IN HEALTHY VOLUNTEERS
Abstract
Development of the medicament on the basis of human angiogenin is innovative, because at the moment there are no angiogenin medications based drugs in the pharmaceutical market. Pilot batch of the recombinant human angiogenin in gel dosage form for external application was synthesized and certified for clinical trials (original medicament "Farmagen"). First phase clinical trials of "Farmagen" medicament was conducted on 28 healthy volunteers. Results of the first phase clinical trials showed safety for external application and high degree of tolerability of "Farmagen". Pharmacokinetics of "Farmagen" for external use was investigated and it was found that when applied to an intact skin surface in healthy volunteers the bioavailability of angiogeninis absent.
About the Authors
A. E. Gulyayev
National Centre for Biotechnology
Russian Federation
Russian Federation
Z. T. Shulgau
National Centre for Biotechnology
Russian Federation
Russian Federation
S. D. Sergazy
National Centre for Biotechnology
Russian Federation
Russian Federation
Z. I. Ashueva
Research Institute of Skin and Venereal Diseases
Russian Federation
Russian Federation
A. A. Tolybekova
Research Institute of Skin and Venereal Diseases
Russian Federation
Russian Federation
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Review
For citations:
Gulyayev A.E., Shulgau Z.T., Sergazy S.D., Ashueva Z.I., Tolybekova A.A. GEL FORM SAFETY AND TOLERABILITY STUDY OF RECOMBINANT HUMAN ANGIOGENIN UNDER TRADE NAME "FARMAGEN" FOR APPLICATION IN HEALTHY VOLUNTEERS. Vestnik SurGU. Meditsina. 2016;(3 (29)):39-47. (In Russ.)
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