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Dosing Begins in Elite Bioequivalence Study

Camargo conducts abuse-deterrence study under 505(b)2

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Camargo Pharmaceutical Services has conducted the first dosing for Elite Pharmaceuticals of a pivotal bioequivalence study in healthy volunteers for an undisclosed opioid abuse deterrent product. The product utilizes Elite’s proprietary pharmacological abuse deterrent technology.

The study is a single-dose, open-label, partially randomized, three-way crossover study in which 52 healthy adult subjects will receive treatment in a partially randomized sequence. The primary objective of this study is to compare the bioavailability of Elite’s abuse-deterrent product to that from the reference listed drug under fasted and fed conditions. The secondary objectives are to determine whether or not subjects receiving the company’s formulation are exposed to naltrexone and to evaluate the safety and tolerability of the product.

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