A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL.
This study will be a randomized study investigating the bioequivalence of COREG CR to its components, COREG and Lisinopril (ZESTRIL). PK samples will be obtained throughout the study to investigate the PK of COREG CR FDC to COREG and Lisinopril
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Randomized, Open-label, Single-dose, Crossover Study to Demonstrate the Bioequivalence of the Final Fixed Dose Combination (FDC) Formulation (COREG CR & Lisinopril) to COREG CR & ZESTRIL Employed in the Phase III Factorial Study|
- To establish bioequivalence of the final FDC product (80 mg carvedilol CR/10 mg lisinopril) relative to concomitant dosing of COREG CR (80 mg) and ZESTRIL (10 mg, over encapsulated)throughout the study [ Time Frame: throughout the study ]
- To further evaluate the pharmacokinetic profile of the final FDC product. To evaluate the safety and tolerability of single doses of the fixed dose combination at the highest dose strengths of each component throughout the study [ Time Frame: throughout the study ]
- plasma levels of carvedilol to determine pharmacokinetic parameters.
- plasma levels of lisinopril determine pharmacokinetic parameters.
|Study Start Date:||September 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Drug: COREG CR
- COREG CR
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552708
|United States, Washington|
|GSK Investigational Site|
|Tacoma, Washington, United States, 98418|
|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|