Elite Pharmaceuticals, Inc. (ELI) Reports Successful Pivotal Bioequivalence Study For Abuse Deterrent Product ELI-200
3/5/2014 9:31:09 AM
NORTHVALE, N.J., March 5, 2014 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) announced today successful results from a pivotal bioequivalence study initiated in January 2014 for Elite's undisclosed abuse deterrent opioid product, ELI-200. The study results demonstrated Elite's product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels. The study was a single dose, open label, partially randomized, three-way cross over study in healthy volunteers with 42 subjects under fasted conditions and 38 subjects under fed conditions.
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