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MOVIPREP^®, originally developed by Norgine, has been marketed in Europe and North America and is the world's most frequently administered bowel preparation prior to colonoscopy. However, MOVIPREP^® is not yet marketed in Japan. AJG522 is essentially similar to MOVIPREP^® but Macrogol (PEG) 3350, one of the main active ingredients of MOVIPREP^®, is replaced by Macrogol 4000 in accordance with Japanese Pharmacopoeia. The objective of the present study was to evaluate the safety and efficacy of AJG522 in healthy Japanese subjects. This study consisted of two steps. In step 1, 12 subjects were administered 1 liter of AJG522 and 0.5 liter of water and repeated twice. They were evaluated for safety and pharmacokinetics of ascorbic acid. In step 2, 50 subjects were administered 1 liter of AJG522 and 0.5 liter of water, and then administered AJG522 until their stool became clear, or 1 liter of AJG522. In both cases the subjects were administered water at half the volume of AJG522. They were also evaluated for safety, pharmacokinetics of ascorbic acid, and cleanliness of the entire colon by colonoscopy. These preparations were well tolerated. One participant dropped out in step 2 before colonoscopy because of eruption, which was mild and resolved without treatment. Successful intestinal cleansing was achieved in 49/49 (100%). This study suggests that AJG522 is safe and useful as a preparation for total colonoscopy. (Jpn J Clin Pharmacol Ther 2013; 44(2): 53-60)

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Recomodulin^® Inj. 12800 (thrombomodulin alfa) was first approved in Japan for the treatment of disseminated intravascular coagulation (DIC). For marketing of Recomodulin, we designed post-marketing surveillance and safety measures with the aim to confirm proper use of the product and to ensure patient safety, according to the ICH E2E Guideline on Risk Management Plan (RMP), which was released by the Ministry of Health, Labour and Welfare. Following the RMP, we first selected safety specifications (SS) according to the results of clinical studies. For the SS chosen, all-case surveillance was designed as a pharmacovigilance plan (PVP), and strict control of both patient selection and product distribution was undertaken as a risk minimization action plan (RiskMAP). After launching of Recomodulin, we evaluated the information from all-case surveillance periodically. The safety measures were adjusted accordingly, taking into consideration the advice received from the Recomodulin Post-Marketing Surveillance Committee of the Japanese Society on Thrombosis and Hemostasis, as well as the feasibility in the clinical setting. Based on the information from 4260 cases in all-case surveillance, it was possible to identify the safety profile of Recomodulin at the early stage of marketing. In addition, strict control of both patient selection and product distribution was useful in confirming patient safety and ensuring the proper use of Recomodulin early after release on the market. (Jpn J Clin Pharmacol Ther 2013; 44(2): 61-69)

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Electronic remote source data verification (RSDV) allows on-site SDV to be performed in a remote place. To use the telecommunication system for such purpose, it is necessary to solve various problems such as personal information protection, data security, operating labor, and cost. In the present study, clinical trial sponsors cooperated in a pilot study of RSDV, which clarified the benefits and identified new problems. We also conducted a questionnaire to investigate the sponsor's satisfaction with the labor involved and the performance for full-scale implementation of RSDV. RSDV was performed using PDF and special code software (FinalCode^®) to investigate the performance and problems. The SDV implementation time per SDV in the medical institution (on-site SDV; OSDV) decreased definitely. However, RSDV had little impact on decreasing the number of times of OSDV, a benefit that was greatly anticipated. From the viewpoint of work density, the quantity of verification data for one OSDV was doubled by the introduction of RSDV. The questionnaire survey showed that, in general, introduction of RSDV increased the convenience of SDV per se. Because all monitors perceived convenience, especially in full support, the survey indicated that convenience outweighs the labor and cost of RSDV. Although this pilot study showed a tendency of decrease in number of SDV, a substantial reduction was not observed. However, the on-site function of re-verifying data that had been confirmed beforehand was well developed, showing a behavioral pattern toward improving the quality of SDV over the time-saving factor. More efforts to improve the efficacy of RSDV would become a driving force to activate clinical trials. (Jpn J Clin Pharmacol Ther 2013; 44(2): 71-76)

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Kremezin^® is an oral adsorbent that has been used for improving uremic symptoms and delaying the initiation of dialysis in patients with chronic kidney disease. Kremezin causes various drug interactions by adsorbing molecules of coadministered drugs in the gastrointestinal tract. In human studies, reduction in plasma concentrations of several drugs including aspirin, amlodipine and triazolam has been reported when administered simultaneously with Kremezin. However, a dosing interval of 30 to 90 min between Kremezin and other drugs renders the interaction insignificant. With limited clinical evidence available currently, it is unlikely that the extent of drug interaction with Kremezin can be predicted accurately. Hence, simultaneous administration of Kremezin with other drugs should be avoided, especially for drugs with narrow therapeutic ranges. Careful monitoring of drug effects and markers including drug levels in serum or blood is necessary in case of concurrent use with Kremezin. (Jpn J Clin Pharmacol Ther 2013; 44(2): 77-84)

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