Quivive Pharma, Inc.
This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are naltrexone-blocked.
This is a Phase 1, single-center, double-blind, randomized crossover study that will be conducted in male and female healthy volunteers. The study will be conducted at a single site in the US. The study consists of a 28-day Screening Period, a four-day treatment period, and a one-day safety follow-up period. The study will be conducted in eight (8) healthy male and female subjects. Up to an additional five (5) subjects may be enrolled as alternates to replace dropouts. Subjects will be randomized (1:1) to one of two crossover treatment sequences. The subjects, Investigators, and site personn…
Key Inclusion Criteria - include but are not limited to: * Male or female aged 18-55 years, inclusive, on the day of screening. * Willing to abstain from alcohol and strenuous physical activity (i.e., strenuous, or unaccustomed weightlifting, running, bicycling, etc.) from 48 hours prior to study treatment administration until discharge from the clinical unit and prior to each outpatient visit. * Have normal laboratory values, as defined per protocol, at screening. * Absence of cardiac arrythmias, as well as corrected QT interval (QTc) \< 450 ms in males and QTc \< 460 ms in females based on…
Hydrocodone bitartrate oral suspension
Doxapram hydrocholoride oral suspension
Arctuva estimate
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