3 results
Approved WMOCompleted
Primary Objective: The primary objective of the study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism, and excretion) of [14C]omacetaxine mepesuccinate and its metabolites in patients with relapsed and/or…
Approved WMOWill not start
(Protocol Am2 dd. 20-Feb-2014, p17/93)The primary objectives of this study are:- To evaluate the safety of sofosbuvir (SOF) 200 mg or 400 mg + ribavirin (RBV) for 24 weeks as assessed by review of the accumulated safety data in each treatment arm-…
Approved WMOCompleted
To assess the bioequivalence of two marketed formulations of ribavirin (ribavirin solution and capsules).