Clinical drug investigation
-
Randomized Controlled Trial Comparative Study
Pharmacokinetics and dose proportionality of fentanyl sublingual spray: a single-dose 5-way crossover study.
Fentanyl sublingual spray is a novel formulation of fentanyl for sublingual delivery that was designed to enhance the rate and extent of absorption of fentanyl for management of breakthrough cancer pain (BTCP). ⋯ In healthy subjects, administration of fentanyl sublingual spray produced a rapid rise in fentanyl plasma concentrations. Dose-dependent parameters (C max and AUC) showed dose proportionality across the range of 100-800 μg. Altering the local environment of the oral cavity (temperature and pH) showed no effects on the bioavailability of fentanyl. The rapid and predictable rise in plasma fentanyl concentrations following administration of fentanyl sublingual spray corresponds with the rapid onset and duration of many BTCP episodes.
-
Randomized Controlled Trial Comparative Study
Cross-over, open-label trial of the effects of gabapentin versus pregabalin on painful peripheral neuropathy and health-related quality of life in haemodialysis patients.
Painful peripheral neuropathy (PPN) is common in haemodialysis patients and associated with impaired health-related quality of life (HR-QoL). Gabapentin and pregabalin have not been fully investigated in haemodialysis patients. Therefore, we compared the effects of gabapentin and pregabalin on intensity of pain and associated HR-QoL in haemodialysis patients with PPN. ⋯ Our results showed strong efficacy of gabapentin and pregabalin on pain intensity in the given doses. HR-QoL was also significantly improved by both drugs.
-
Randomized Controlled Trial Comparative Study
Pharmacokinetics, tolerability, and safety of intranasal administration of reformulated OxyContin(®) tablets compared with original OxyContin (®) tablets in healthy adults.
Reformulated OxyContin(®) (oxycodone-HCl controlled release) tablets (ORF) became available in the United States in August 2010. The original formulation of OxyContin(®) (oxycodone-HCl controlled release) tablets (OC) used a delivery system that did not provide inherent resistance to crushing and dissolving. The objective of this study was to compare the pharmacokinetics, tolerability, and safety of finely crushed ORF tablets, coarsely crushed ORF tablets, and finely crushed OC tablets. ⋯ In contrast to OC, both finely and coarsely crushed ORF retained some control of oxycodone release. Reduced C(max) and increased t max for ORF resulted in lower AQ scores for ORF compared with OC. ORF was associated with greater intranasal irritation than OC. These data suggest that ORF has a lower intranasal abuse potential than OC.