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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00552708 |
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
Condition | Intervention | Phase |
Hypertension |
Drug: COREG CR Drug: Lisinopril |
Phase I |
MedlinePlus related topics: | High Blood Pressure |
ChemIDplus related topics: | Lisinopril Carvedilol |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study |
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 |
Enrollment: | 55 |
Study Start Date: | October 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Study ID Numbers: | CFD108412 |
First Received: | October 31, 2007 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00552708 |
Health Authority: | United States: Food and Drug Administration |
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