Elite Pharmaceuticals Inc (ELTP)

[Steges]

The study, initiated in July of 2014, demonstrated Elite’s product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) as measured for opioid blood plasma levels. The study was a single dose, open label, randomized, cross-over study in healthy volunteers with 34 subjects conducted under fasted conditions Final findings of bioequivalence are dependent upon FDA review.

Oxycontin (Oxycodone Hydrochloride) - Description and Clinical Pharmacology: http://www.druglib.com/druginfo/oxycontin/description_pharmacology/

See: "PHARMACOKINETICS AND METABOLISM"