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Wednesday, May 25, 2016 10:36:06 AM
The pilot clinical trial produced the following results:
The Rexista™ product demonstrated sustained release pharmacokinetic activity, with blood plasma concentrations at clinically significant levels over a 24 hour period.
The bioavailability of a single dose of the Rexista™ product, as measured by Cmax and AUC, was comparable to that of two doses of OxyContin® dosed at 12 hour intervals. Both Cmax and AUC were in the 80% - 125% range as compared to OxyContin®, demonstrating effective bioequivalence with the branded product.
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