This study will be a randomized study investigating the bioequivalence of COREG CR and Lisinopril to COREG CR and ZESTRIL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
GSK Investigational Site
Buffalo, New York, United States
Blood Sampling over a period of 96 hours post dosing of Investigational product in all sessions. Safety: ECG, Vital Signs, clinical labs over 96 hours post dosing. Continuous Adverse event monitoring from dosing until study conclusion and followup.
Time frame: 96 hours
To assess other pharmacokinetic parameters, evaluate the safety and tolerability Safety: ECG, Vital Signs, Clinical labs over a 96 hour period following dose of investigational product. Continuous adverse event report for ever session
Time frame: 96 Hours
PK parameters: Tmax and t1/2 of carvedilol [racemate] and lisinopril.
Safety and tolerability will be assessed by clinical data from Adverse Event reporting, nurse/physician observations, vital signs, ECGs, and clinical laboratory.
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