/ Active, not recruitingPhase 1 Characterization of Relative Bioavailability of a Newly Developed Esflurbiprofen Topical System (EFTS) in Comparison with a Marketed Oral Flurbiprofen-containing Tablet Formulation After Multiple-dose Administration Including EFTS Adhesion Assessment - a Phase I, Open-label, Randomized, 2-period, Cross-over Study in Healthy Subjects
This study is a single-center, open-label, multiple-dose trial performed in a 2-period, 2- sequence-cross-over design in healthy volunteers. The primary purpose of this study is to assess non-superiority of the bioavailability of TK-254RX compared with that of a marketed oral flurbiprofen-containing tablet formulation in healthy volunteers in a 2-period, 2- sequence-cross-over design and evaluate adhesion of TK-254RX. Secondary purpose is to assess safety of TK-254RX and residual amount of the patch.
A Randomized, Two-way, Crossover, Two Parallel Groups Study to Compare the Bioavailability of 150 Mg and 300 Mg Trazodone Hydrochloride Tables (new Polymer) Vs. 150 Mg and 300 Mg Trazodone Hydrochloride Contramid® Tables At Steady-state.
Two way, two parallel groups, crossover study to compare the bioavailability of 150 mg and 300 mg trazodone hydrochloride (new polymer) (Angelini Pharma S.p.A.) vs. 150 mg and 300 mg trazodone hydrochloride Contramid® (Angelini Pharma S.p.A.) at steady-state in 64 Healthy Volunteers.
Comparative, Randomized, Open, Crossover Clinical Trial to Investigate Adhesiveness of a Newly Developed Rotigotine-containing Transdermal Patch in Patients With Parkinson's Disease
The investigational medicinal product (IMP) to be tested in the clinical trial (Rotigotine (ROT)-Transdermal System (TDS) (8 mg/24 h)), which is subject to this submission, was designed as a generic of Neupro® 8 mg/24 h, which is marketed in the European Union since 2006 (date of first authorisation is 2006, date of renewal of the authorisation is 2016) and serves as Reference product.
It is the intention of this clinical trial to assess patch adhesion properties of the newly developed rotigotine patch and the marketed Reference product Neupro® 8 mg/24 h after multiple patch applications.
100 Clinical Results associated with SocraTec R&D Concepts in Drug Research & Development GmbH
0 Patents (Medical) associated with SocraTec R&D Concepts in Drug Research & Development GmbH
100 Deals associated with SocraTec R&D Concepts in Drug Research & Development GmbH
100 Translational Medicine associated with SocraTec R&D Concepts in Drug Research & Development GmbH