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 gran

In early November, IPHARMA received two approvals from the Ministry of Health of the Russian Federation to conduct phase I clinical trials of Ventvil® and Slavinorm® medicinal products. Protocol № HEP-VTL-01 "A double-blind, randomized, placebo-controlled study of the safety and tolerability of increasing doses of Ventvil® for single and subsequent multiple intramuscular administration in healthy volunteers." The study objective is to evaluate the safety and tolerability of i

On October, 30 IPHARMA received the Ministry of Health permission to conduct Phase I trial of Hondrolux® Protocol № ОА-CLX-01 “Double-blind, randomized, placebo-controlled study to access safety and tolerability of single and following multiple escalating doses of the Khondrolux® study drug after a single and subsequent multiple intramuscular injection in healthy volunteers”. The purpose of the clinical trial is to evaluate the safety and tolerability of the Khondrolux® with

On June 7, 2017, IPHARMA had received the Ministry of Health of the Russian Federation permission to conduct a Phase I clinical trial of Testonorm®. Protocol No. ANDR-TSN-01 "Double-blind, randomized, placebo-controlled study of the safety and tolerability of increasing doses of Testonorm® with single and subsequent multiple intramuscular injection in healthy volunteers." The purpose of the clinical study: evaluate the safety profile and tolerability of the drug Testonorm® fo

On May 30, 2017 IPHARMA received Ministry of Health permission to conduct a Phase I clinical trial of CD-008-0045. Protocol No. CD-008-0045 "A double-blind, randomized, placebo-controlled study of the safety, tolerability, and pharmacokinetics of increasing doses of CD-008-0045 for single and multiple dosing in healthy volunteers." The purpose of the clinical study: assess the safety and tolerability of the preparation CD-008-0045 for single and multiple use in healthy volunt

On May 22, 2017 IPHARMA received the Ministry of Health permission to conduct clinical trial of Phase I of the drug XC221. Protocol #ARI-XC221-01 "Double-blind randomized placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing doses of the drug XC221 for single and subsequent oral administration in healthy volunteers." The purpose of the clinical trial is the evaluation of the safety profile and tolerability of the dr

On December, 14th at 11:00 am, we will hold a webinar on the “Phase I and Bioequivalence clinical trials”. Early phase studies is the most important stage of the drug development process. Firstly, volunteers and patients take medicine for the first time ever, so it can be dangerous. Secondly, the decision about the future of the drug can be made. So we make specific demands to the sites. It will be discussed on the webinar. Register to webinar What will we discuss in Webinar?

In August 2016, IPHARMA LLC was authorized by the Ministry of Healthcare of the Russian Federation to conduct the Phase I clinical trial of medicinal product ИД-4025. Protocol № HCV-ИД4025-04 "Double-blind randomized placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of rising doses of ИД-4025 for single oral use in healthy subjects". Study Objective: to evaluate the safety and tolerability of ИД-4025 for single use in healthy subjects. The are

On 25th of April, 2016, IPHARMA was authorized by the Ministry of Healthcare of the Russian Federation to conduct the Phase I clinical trial of the medicinal product XC125. Protocol № ARI-XC125-01 "Double-blind randomized placebo-controlled clinical study of safety, tolerability, pharmacokinetics and pharmacodynamics of rising doses of XC125 for single and multiple oral use in healthy subjects". The purpose of this clinical trial is to study safety, tolerability, pharmacokine