Hydrocodone bitartrate (HB) and acetaminophen (APAP) combination products are known to be abused via oral, intranasal, and intravenous self-administration. Benzhydrocodone HCl (KP201) is a prodrug of hydrocodone with limited bioavailability when taken intranasally or intravenously, or taken orally at supratherapeutic doses. This study assessed the abuse liability, relative bioavailability, and safety of KP201/APAP, compared with that of HB/APAP (Norco®), when administered at supratherapeutic oral doses to non-dependent, recreational opioid users. Both KP201/APAP and HB/APAP were generally well tolerated and had similar Drug Liking scores, but KP201/APAP displayed lower peak and cumulative systemic exposure to hydrocodone at high and mid oral doses.
PRA Successfully Delivers A Complex Phase I Psoriasis Study
Exceptional Support and Innovative Strategies Combat Study Challenges.
Human ADME Studies With Radiolabeled Compounds Phase I-IIa
Radiolabeled medication is widely used in the assessment of human ADME and also increasingly in assessing absolute bioavailability (BA). Conducting…
Bioanalysis, Biomarker and Flow Cytometry Assay List
Bioanalysis, Biomarker and Flow Cytometry Assay List. PRA Laboratories—Solutions for Drug Development. Behind every sample waiting to be analyzed,…