A Phase 1 interventional study of AZD9056 formulation Phase III 50 mg (T) and AZD9056 formulation Phase IIb 50 mg (R) in Healthy, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-23.
Sponsored by AstraZeneca · Phase 1 and Interventional
The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.
AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 or 400 mg AZD9056, Test formulation
Drug: AZD9056 formulation Phase III 50 mg (T) · Drug: AZD9056 formulation Phase III 200 mg (T)
50 or 400 mg AZD9056, Reference formulation
Drug: AZD9056 formulation Phase IIb 50 mg (R) · Drug: AZD9056 formulation Phase IIb 200mg (R)
Given as 50 mg tablet (T)
Given as 50 mg tablet (R)
Given as 400 mg (2 x 200 mg tablet (T))
Given as 400 mg (2 x 200 mg tablet (R))
Relative bioavailability of AZD9056 using PK variables Cmax and AUC
Time frame: 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
Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F)
Time frame: 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)
Time frame: Frequent sampling occasions throughout the study period
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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AstraZeneca