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Bioavailability and Pharmacodynamics of Promethazine in Human SubjectsThe acute effects of exposure to microgravity include the development of space motion sickness, which usually requires therapeutic intervention. The current drug of choice, promethazine (PMZ), is available to astronauts in three different dosage forms during space flight; its side effects include nausea, dizziness, sedation and impaired psychomotor performance. This ground-based study is designed to validate flight-suitable methods for pharmacodynamic evaluation of PMZ and to estimate bioavailability and pharmacodynamics of PMZ. Experimental design consists of intramuscular administration of three doses of PMZ (12.5,25 and 50 mg) and placebo in a randomized double blind fashion to human subjects and collecting blood, urine and saliva samples for 72 h. Subjects also complete cognitive performance test batteries, WinSCAT (Windows based Space Cognitive Assessment Test) and ARES (ANAM Readiness Evaluation System). Preliminary results indicate a significant relationship (p=9.88e-05) between circulating PMZ levels and cognitive performance parameters. Time to accurately complete memory tasks increases significantly with concentrations; higher concentrations also increase response time and decrease accuracy of substitution and matching tasks. AUC and half-life estimates for PMZ ranged between 0.12 and 1.7 mg.h/L and 15 and 50 h, respectively. These preliminary results indicate that PMZ may exhibit dose-dependent pharmacokinetics in humans; also, WinSCAT and ARES are sensitive for pharmacodynamic assessment of PMZ, and may be applicable for assessing the pharmacodynamics of other neurocognitive drugs.
Document ID
20050220676
Acquisition Source
Johnson Space Center
Document Type
Conference Paper
Authors
Boyd, J. L.
(Universities Space Research Association Houston, TX, United States)
Boster, B.
(Wyle Labs., Inc. Houston, TX, United States)
Wang, Z.
(Wyle Labs., Inc. Houston, TX, United States)
Shah, V.
(Wyle Labs., Inc. Houston, TX, United States)
Berens, K. L.
(Wyle Labs., Inc. Houston, TX, United States)
Sipes, W. E.
(Wyle Labs., Inc. Houston, TX, United States)
Anderson, K. E.
(Texas Univ. Galveston, TX, United States)
Putcha, L.
(NASA Johnson Space Center Houston, TX, United States)
Date Acquired
August 23, 2013
Publication Date
January 1, 2004
Subject Category
Aerospace Medicine
Distribution Limits
Public
Copyright
Other

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