Baltimore, MD (PRWEB) December 06, 2014
SNBL Clinical Pharmacology Center, Inc. (SNBL CPC), a 96-bed clinical pharmacology research unit specializing in complex early-phase trials, announced today the successful completion of two Japanese Bridging studies investigating the pharmacokinetics and safety parameters of an investigational product under an IND application.
The first study was a single-dose crossover study that evaluated the safety and pharmacokinetics of two formulations of the IP in 24 healthy adult Japanese male and female volunteers. The second study was a multiple ascending dose crossover study that evaluated safety and tolerability of the investigational product.
Because of the unusually high stringency of inclusion and exclusion criteria for Japanese heritage, both studies utilized a unique recruitment strategy to ensure 100% enrollment of eligible Japanese subjects. Participants were recruited not only from the surrounding mid-Atlantic area, but also directly from Japan. A total of 44 Japanese subjects, representing a 100% recruitment rate, were enrolled in the two studies. The target sample size was met for both studies, with only one subject each not completing all assessments. For both studies the clinical database was locked two weeks after the last patient visit of the study.
SNBL CPC is an American subsidiary of Japan’s first early phase contract research organization, Shin Nippon Biomedical Laboratories (SNBL). Thanks to this heritage, SNBL CPC is well-equipped to provide the best care for Japanese subjects by providing Japanese amenities and support. Integral Japanese-speaking support staff included a research physician who has been with SNBL CPC since 2006, and several translators who assisted with recruitment and clinical conduct. Feedback from Japanese participants regarding their experiences throughout the trial was positive, demonstrating the success of SNBL CPC’s approach to providing Japanese-style care. Some participants indicated an interest in returning for future studies. All these factors contributed to the flawless conduct of the trials, the 100% recruitment rate and nearly 100% retention rate.