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IPHARMA received the Ministry of Health approval to conduct two clinical trials

21.12.2017

IPHARMA got two Ministry of Health approvals for clinical trials conduction at once in December:

  • Phase III clinical study of the medical product OKITASK(Ketoprofen lysine salt)

  • Phase I clinical study of the medical product BI-MAB-03(Trastuzumab)

Medical product OKITASK® is developed by a company “DompeFarmateutichy S.p.A.”. it is a Propane acid salt of L-lysin.

 

KSL0117  A double blind, randomised, parallel groups study to assess the efficacy and tolerability after single oral administration of OKITASK®40 mg granules (Ketoprofen lysine salt 40 mg) versus Placebo in male and female subjects with acute pain syndrome after removal of molar teeth.

 

The goal of the trial is to assess the efficacy and tolerability after single oral administration of Ketoprofen lysine salt versus placebo in male and female subjects with acute pain syndrome after removal of molar teeth.

 

Therapeutic area: stomatology.

 

Medical product BI-MAB-03(Trastuzumab) is developed by a company “BioIntegrator”. It is a lyophilizate for preparing of fluid for infusions.

 

ONC-BIMAB03-01 A multicenter, double-blind, randomized clinical study of the safety, tolerability, pharmacokinetics and immunogenicity of the bio-like BI-MAB-03 compared to the original Herceptin®in healthy volunteers.

 

The goal of the trial is to assess the safety, tolerability, pharmacokinetics and immunogenicity of the bio-like BI-MAB-03 (Trastuzumab) compared to the original Herceptin®in healthy volunteers.

 

Therapeutic area: oncology.

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