definiens: means a clinical trial of an investigational prod uct in patients with the primary objective of characterizing its activity in a speci fic disease state as well as generating more detail ed safety, tolerability, pharmacokinetics, and dosing information as described in 21 C.F.R. 312.21(b ), or a comparable Clinical Trial prescribed by the relevan t Regulatory Authority in a country other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. 312.21(a ) or corresponding foreign regulatio ns and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b ) ( or corresponding foreign regulations ) or otherwise to enable a Phase III Clinical Trial ( e.g., a Phase I / II Clinical Trial ) . The investigational product can be administered to patients as a single agent or in co mbination with other investigational or marketed agents