A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00552708|
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : October 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: COREG CR Drug: Lisinopril||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- Drug: COREG CR
- Drug: Lisinopril
Other Name: COREG CR
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552708
|United States, Washington|
|GSK Investigational Site|
|Tacoma, Washington, United States, 98418|
|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|