A Relative Bioavailability Study of a Fixed Dose Combination (FDC) Tablets of GSK587323
Status:
Completed
Trial end date:
2014-05-23
Target enrollment:
Participant gender:
Summary
This study is required to confirm the suitability of a candidate FDC of 16mg candesartan
cilexetil/12.5mg HCTZ (GSK587323) formulation for further development and provide data to
allow the design of a future pivotal bioequivalence study. This study aims to determine the
relative bioavailability of a FDC tablet formulation of 16mg candesartan cilexetil/12.5mg
HCTZ relative to the reference product of same fixed dose combination (16mg candesartan
cilexetil/12.5mg HCTZ) in healthy adult humans. This will be an open-label, randomised,
single dose, two-way crossover study. Each subject will participate in two treatment periods
and will be randomized to one of two sequences and administered one of the two treatments, A
or B, as per the randomization schedule. The two treatment periods will be separated by a
washout period of 7 to 14 days to ensure the candesartan and HCTZ have been effectively
eliminated from the subject between dosing occasions. The study will enroll 16 healthy
subjects to ensure that 14 subjects complete the study as planned.