Relative Bioavailability Study in Healthy Subjects Compar... | NCT02367027 | Trialant

Relative Bioavailability Study in Healthy Subjects Compar... | NCT02367027 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1 - BAY59-7939	Experimental	10 mg oral suspension (dry powder) in fasted conditions	Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arn 2 - BAY59-7939	Experimental	20 mg oral suspension (dry powder) in fed conditions.	Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 3 - BAY59-7939	Experimental	10 mg oral suspension in fasted conditions	Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 4 - BAY59-7939	Experimental	10 mg tablet in fasted conditions.	Drug: Rivaroxaban (Xarelto, BAY59-7939)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentration of rivaroxaban characterized by AUC	AUC:area under the concentration vs. time curve from zero to infinity after single (first) dose	Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours), at 48 hr after administration), at 72 hr after administration)
Plasma concentration of rivaroxaban characterized by AUC/D	AUC/D: AUC divided by dose	Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours),at 48 hr after administration),at 72 hr after administration)
Plasma concentration of rivaroxaban characterized by Cmax	Cmax: maximum drug concentration in plasma after single dose administration	Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours),at 48 hr after administration),at 72 hr after administration)
Plasma concentration of rivaroxaban characterized by Cmax/D	Cmax/D: Cmax divided by dose	Dosing day(15 min, 30 min ,45 min ,1 ,1.5, 2, 2.5 ,3 , 4, 6,8,12,15 hours),at 48 hr after administration),at 72 hr after administration)

Contacts/Locations Module