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Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure

2014-08-27 03:15:09 | BioPortfolio

Summary

- Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous infusion on Pulmonary Arterial Pressure as determined by echocardiography.

- Assess the Pharmacokinetics of DHE and its metabolites in relation to the parent component.

- Compare the acute effects and tolerability of DHE delivered by Oral Inhalation (MAP0004) versus by intravenous infusion on cardiac function other than pulmonary arterial pressure as determined by echocardiography.

- Compare the pharmacodynamics and pharmacokinetics of DHE delivered by Oral Inhalation (MAP0004) to a single dose of DHE Delivered Intravenously (IV DHE)

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treat

Conditions

Healthy

Intervention

MAP0004, IV Placebo, Placebo Inhaler, DHE 45

Location

Duke Clinical Research Unit
Durham
North Carolina
United States
27710

Status

Active, not recruiting

Source

MAP Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:09-0400

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