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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00549510 |
This will be an open-label, single-dose, non-randomized, five-period crossover study in healthy volunteers. The duration of the study will last up to eleven weeks from screening to follow-up. PK samples will be taken.
Condition | Intervention | Phase |
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Hypertension |
Drug: COREG CR and lisinopril (FDC) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Non-Randomized, Open-Label, Single-Dose, Crossover Study to Evaluate the Dose Proportionality of the Final Fixed Dose Combination Formulation of COREG CR™ and Lisinopril. |
Enrollment: | 29 |
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:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CFD108407 |
Study First Received: | October 23, 2007 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00549510 History of Changes |
Health Authority: | United States: Food and Drug Administration |
COREG CR, lisinopril, hypertension, dose proportionality, fixed dose combination (FDC) |
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Lisinopril Vascular Diseases Cardiovascular Agents Adrenergic alpha-Antagonists |
Antihypertensive Agents Protease Inhibitors Adrenergic beta-Antagonists Angiotensin-Converting Enzyme Inhibitors Adrenergic Antagonists Hypertension Carvedilol |
Vasodilator Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Lisinopril Physiological Effects of Drugs Vascular Diseases Enzyme Inhibitors Adrenergic alpha-Antagonists Cardiovascular Agents |
Antihypertensive Agents Protective Agents Pharmacologic Actions Protease Inhibitors Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Hypertension Carvedilol |