Int J Clin Pharm Th
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Int J Clin Pharm Th · Jun 2013
Randomized Controlled TrialAn innovative phase I population pharmacokinetic approach to investigate the pharmacokinetics of an intranasal fentanyl spray in healthy subjects.
Intranasal Fentanyl Spray (INFS) was developed for the treatment of breakthrough pain (BTP) in cancer patients using a new route of administration. Dose strengths of 50, 100, and 200 μg INFS (Instanyl®) are currently on the market, however, some adult cancer patients with BTP may require higher doses up to 400 μg INFS. ⋯ The implementation of a PopPK approach in the planning and analysis of this trial yielded an innovative, cost- and time-saving trial design that successfully delivered the required information about the PK of the 400 μg dose strength within this small clinical study.