This will be an open-label, randomized, single dose, two-way crossover study. Each subject will participate in both treatment periods and will receive single oral doses of candesartan cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™); the treatment periods will be separated by a washout period of at least 7 days and no greater than 14 days. This study aims to determine the relative bioavailability of an 8mg test formulation tablet of candesartan cilexetil (GW615775) compared to an 8mg reference tablet of candesartan cilexetil in healthy adult subjects. ATACAND is a registered trademark of the AstraZeneca group of companies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Test formulation candesartan cilexetil 8 mg will be supplied as round, biconvex pink tablets with PX 8 embossed in one face.
Reference treatment of candesartan cilexetil 8 mg will be supplied as round, biconvex pink tablets, scored in one face and with embossment in both faces (008 embossment in the plain face and A CG in the scored face).
GSK Investigational Site
Hyderabad, India
Plasma pharmacokinetic (PK) parameters assessed by Cmax, AUC(0-infinity) and AUC(0-t)
PK parameters include: Maximum observed concentration (Cmax), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC\[0-infinity\]) and area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments \[AUC(0-t)\].
Time frame: Pre-dose, 0.5 hour (hr), 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr and 48 hr of each treatment period.
PK parameters assessed by tmax, %AUCex and t1/2
PK parameters include: Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex), time of occurrence of Cmax (tmax), terminal phase half-life (t1/2).
Time frame: Pre dose, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr and 48 hr of each treatment period.
Safety and tolerability assessment as assessed by adverse events (AEs)
Time frame: Up to 35 days
Safety and tolerability assessment as assessed by vital signs
Vital sign measurements will include systolic and diastolic blood pressure, and pulse rate.
Time frame: Up to 35 days
Safety and tolerability assessment as assessed by clinical laboratory values
Clinical laboratory assessments will include hematology, clinical chemistry, routine urinalysis and additional parameters.
Time frame: Up to 35 days
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