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Sponsored by: |
Prism Pharmaceuticals |
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Information provided by: | Prism Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00420953 |
Determine the relative bioavailability of PM101 I.V. and Cordarone I.V.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Cordarone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Randomized, Double-Blind, 2-Period Crossover Trial to Determine the Relative Bioavailability of PM101 I.V. (Amiodarone HCl) and Cordarone I.V. in Healthy Adult Volunteers |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 101 |
Study First Received: | January 8, 2007 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00420953 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Healthy Amiodarone |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Cardiovascular Agents Anti-Arrhythmia Agents Pharmacologic Actions |