Clinical trials should be accelerated to deliver the newly developed medicine and equipment to patients. Therefore, it is important to increase the number of candidates for clinical trials. Since February 2011, we have made original posters for recruiting clinical trial candidates and released information of ongoing clinical trials on the internet website. We have also distributed clinical trial information to the general public during the annual clinical trial educational seminar (seminar). To evaluate the effectiveness of these measures, we reviewed medical record during fiscal years 2009-2014 to identify subjects who participated in clinical trials by their own initiative. The results were compared between the period 2009-2010 before the measures were implemented (control) and for the period 2011-2014 after the measures were implemented. Although the number of participants increased apparently for 2011-2014, the difference was not significant (p=0.054). For 2009-2014, 13 participants (57%) were referred by primary care doctors. The subjects who participated through posters and internet were significantly younger than those who participated through referral by primary care doctors (mean age: 37.8 years vs. 54.7 years; p=0.007). Although participants of the seminar responded that the image of clinical trial was improved, no person participated in clinical trial through clinical trial information distributed in the seminar. From these results, one of the best methods to recruit trial subjects may be dissemination of clinical trial information to primary care doctors for the elderly. On the other hand, the guardians who accompanied children to attend the new children's seminar in February 8, 2015 were 30 to 40 years of age (99%). These parents may be the new targets for clinical trial candidate recruitment.
FENTANYL Tape for 1 Day ⌈MEIJI⌋ is a generic drug of OneDuro® Patch (Janssen Pharmaceutical K.K.) under development by Meiji Seika Pharma Co., Ltd. and Yutoku Pharmaceutical Ind. Co., Ltd. The generic drug contains the same active ingredient fentanyl at the same dose in the same dosage form (transdermal absorption) as the original drug. In this study, 32 healthy male Japanese adults were recruited as subjects. Each subject applied a FENTANYL Tape for 1 Day 0.84 mg ⌈MEIJI⌋ and a OneDuro® Patch 0.84 mg once in a crossover manner, without concomitant use of antinarcotic. Bioequivalence of these drugs was investigated by analyzing pharmacokinetic parameters (Cmax and AUC0→t) as primary endpoints calculated from serum fentanyl concentration profiles in all 32 subjects. The results confirmed bioequivalence of the two products. Secondary endpoints including pharmacokinetic parameters such as AUC0→∞, MRTt and kel also supported bioequivalence of the two products. When a FENTANYL Tape for 1 Day 0.84 mg ⌈MEIJI⌋ or a OneDuro® Patch 0.84 mg was applied once for 24 hours without concomitant use of antinarcotic, there were no adverse events such as cutaneous reactions at the application site.
Tolerability, safety, pharmacokinetics, and pharmacodynamics of orally administered macitentan at 3 and 10 mg once daily for 10 days were investigated in 16 healthy Japanese male subjects in a randomized, placebo-controlled, double-blind, single-center study. Plasma concentrations of macitentan were found to peak at 5 hr, with a mean terminal elimination half-life of approximately 11 hr, for both doses of macitentan. Furthermore, the active metabolite of macitentan, ACT-132577, demonstrated a longer elimination half-life (approximately 48 hr). Area under the plasma concentration-time curve (AUC) of endothelin-1 was significantly higher in the macitentan 10-mg group compared with the placebo group (exploratory p value, 0.0154). No critical issues regarding the safety and tolerability of macitentan were observed, including time-matched electrocardiographic (ECG) evaluations. The results of this study in healthy Japanese male subjects corroborate with previous studies in Caucasian and Korean subjects. In conclusion, the macitentan dose range from 3 to 10 mg had a good safety and tolerability profile in healthy Japanese male subjects, and its pharmacokinetics and pharmacodynamics were dose-dependent without ethnic differences.