Analgesia Disorder Clinical Trial
Official title:
The Pharmacokinetic and Bioavailability Studies of PHN131, an Oral Formulation of Nalbuphine Hydrochloride, in Healthy Volunteers
To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability of PHN131 in healthy volunteers
1. Efficacy endpoint(s): the pharmacokinetic properties and bioavailability of PHN131 The
efficacy endpoint will be the pharmacokinetic properties after administered PHN131 such
as the concentration of nalbuphine in plasma and pharmacokinetic parameters of PHN131
analyzed from the concentration of nalbuphine in plasma. The bioavailability of PHN131
will be calculated from the pharmacokinetic parameters of PHN131 and Nubain® injection.
2. Safety evaluation:
The safety evaluation will include the vital signs monitoring such as blood pressure, pulse
rate, body temperature and respiratory rate in the treatment period.
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Observational Model: Case-Crossover, Time Perspective: Prospective
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