Study to Examine the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination of COREG CR and Lisinopril.
This is a randomized, open-label, single-dose, period-balanced, three-period crossover study conducted in healthy subjects designed to evaluate whether the absorption of the FDC formulation is affected by the ingestion of a high fat meal or is altered when taken in a fasted state.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-label, Single-dose, 3-period Crossover Study to Assess the Effect of Food on the Pharmacokinetics of the Final Fixed Dose Combination Formulation of COREG CR and Lisinopril in the Fed and Fasted State.|
- The effect of food on PK after high fat and standard meal Blood sampling over a 72 hour period post dose in all dosing sessions [ Time Frame: 72 hour period post dose in all dosing sessions ]
- Food effect on PK over 72 hours after meals compared to fasting, safety and tolerability assessed by spontaneous Adverse Event reporting, nurse/physician observations, vital sign assessment, ECGs, and clinical labs over 3 session crossover [ Time Frame: 72 hours after meals ]
- Other pertinent pharmacokinetic parameters of carvedilol and lisinopril, as data permit, such as Tmax and t1/2 of carvedilol and Tmax and t1/2 of lisinopril
|Study Start Date:||November 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Drug: COREG CR and lisinopril (FDC)