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This study will be a randomized study investigating the bioequivalence of COREG CR and Lisinopril to COREG CR and ZESTRIL
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COREG CR | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 96 Hours | |
| PK parameters: Tmax and t1/2 of carvedilol [racemate] and lisinopril. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14202 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Safety and tolerability will be assessed by clinical data from Adverse Event reporting, nurse/physician observations, vital signs, ECGs, and clinical laboratory. |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |