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

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 (Transtusumab)

Medical product OKITASK® is developed by “Dompe Farmateutici S.p.A.”. It is a propionic acid L-lysine salt.

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

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

Therapeutic area: stomatology.

Medical product BI-MAB-03(Trastusumab) is developed by “BioIntegrator” company. It is a lyophilisate for preparation of solution for infusions.

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

Therapeutic area: oncology.

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