single-centre, randomised, open-label, single-dose, seven-way cross-over trial

[LenaK]

single-centre, randomised, open-label, single-dose, seven-way cross-over trial?
wash-out days?
run-in period?
cross-over period?

Trial 248.529 was a single-centre, randomised, open-label, single-dose, seven-way cross-over trial ([U05-2046]) to compare the bioavailability of seven prototypes ER formulations (B, C, D, E, F, G and H) to IR tablets. After a run-in period of 7 days (with increasing pramipexole
IR doses up to 0.25 mg t.i.d.), each of the seven ER formulations was given for four days (without wash-out days) in a seven-way cross-over design. Eighteen HVs entered the run-in phase and 14 entered the cross-over period.

ER:extended-release IR: immediate release HV: healthy volunteers