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Sponsored by: |
Prism Pharmaceuticals |
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Information provided by: | Prism Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00502346 |
The primary objective of the study is to compare the effect of PM101 I.V. administered as an immediate intravenous bolus versus placebo on systolic blood pressure. Secondary objectives include evaluation of change from baseline in heart rate and change from baseline to the lowest value in mean arterial pressure and diastolic pressure.
Condition | Intervention | Phase |
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Healthy |
Drug: PM10 |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial to Determine the Relative Effect of PM101 I.V. Versus Placebo on Hemodynamics in Healthy Adult Volunteers |
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: | 102 |
Study First Received: | July 10, 2007 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00502346 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pharmacodynamics |
Healthy |