AZD9056 Relative Bioavailability Study | NCT00908934 | Trialant

AZD9056 Relative Bioavailability Study | NCT00908934 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	50 or 400 mg AZD9056, Test formulation	Drug: AZD9056 formulation Phase III 50 mg (T) Drug: AZD9056 formulation Phase III 200 mg (T)
2	Experimental	50 or 400 mg AZD9056, Reference formulation	Drug: AZD9056 formulation Phase IIb 50 mg (R) Drug: AZD9056 formulation Phase IIb 200mg (R)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relative bioavailability of AZD9056 using PK variables Cmax and AUC		For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7

Secondary Outcomes

Measure	Description	Time Frame
Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F)		For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7
Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)

Contacts/Locations Module