4 results
- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 7 days per dosing cycle - Evaluate the pharmacokinetics of gemcitabine and 2',2'-difluorodeoxyuridine (dFdU, a gemcitabine-related metabolite) exposure in…
The objectives of this study are to:- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 21 days per dosing cycle.- Evaluate the pharmacokinetics of gemcitabine and 2', 2'-difluorodeoxyuridine (dFdU, a…
Primary• To assess the efficacy of a fixed dose of pregabalin to placebo during the first12-week treatment period in subjects with RLS.• To compare the rate of augmentation of a fixed dose of pregabalin to 2 fixed doses ofpramipexole over 9 or 12…
This study is designed to demonstrate equal therapeutic effect of Myfortic® as compared to MMF in this patient group, thus improving therapeutic efficacy.