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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date07 Dec 1967 |
A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Siklos® in Healthy Volunteers
This study is a Phase I, open-label, single-centre, randomised, two-period, single-dose crossover study to compare and assess the bioequivalence, safety, tolerability and pharmacokinetics of hydroxycarbamide dispersible tablets (20 x 50 mg) (test IMP) and Siklos® film-coated tablet (1000 mg) (reference IMP) following single-dose administration. Thirty (30) healthy male and female participants, between 18 and 50 years of age are planned to participate in the study.
Study participants will be randomised to one of the 2 possible combination sequences. After each treatment administration, blood samples will be collected at specific time points to assess the Pharmacokinetics (PK) parameters.
Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease
The purpose of this study is to evaluate the relationship between plasma DNA levels and micro- and macro-circulatory vascular remodelling in patients with sickle cell disease
Validation of a Predictive Score of Acute Chest Syndrome
Vaso-Occlusive Crisis (VOC), the most common manifestation of sickle cell disease (SCD), is the first cause of death, particularly when complicated by an acute chest syndrome (ACS).
The PRESEV score could help the physicians to better manage VOC and could be used for future therapeutic trials. This predictive score of secondary ACS has to be validated in a multicenter international study.
100 Clinical Results associated with Addmedica SAS
0 Patents (Medical) associated with Addmedica SAS
100 Deals associated with Addmedica SAS
100 Translational Medicine associated with Addmedica SAS