This will be an open-label, single-dose, non-randomized, five-period crossover study in healthy volunteers. The duration of the study will last up to eleven weeks from screening to follow-up. PK samples will be taken.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
GSK Investigational Site
Austin, Texas, United States
Assessment of dose proportionality by comparison of PK parameters across dosing range Blood sampling over up to a 120 hour period post dose in all dosing sessions
Characterization of PK, safety and tolerability Safety and tolerability will be assessed by clinical data from spontaneous Adverse Event reporting, nurse/physician observations, vital sign assessment, ECGs, and clinical laboratory tests
The pharmacokinetic parameters to be evaluated are the Tmax and t1/2 of carvedilol [R(+) and S(-)enantiomers] and Tmax and t1/2 of lisinopril
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.