AJG522 の日本人健康成人における安全性および大腸内視鏡検査前処置に対する有効性の検討
スポンサーリンク
概要
- 論文の詳細を見る
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)
- 一般社団法人 日本臨床薬理学会の論文
一般社団法人 日本臨床薬理学会 | 論文
- 臨床家の立場より : 脳循環代謝改善薬
- 生体肝移植ならびに小腸移植術後のタクロリムス投与方法
- 甲状腺機能低下によりWarfarin効果の減弱がみられた症例
- 治験の品質管理における治験コーデイネーターの役割
- 治験,臨床試験,臨床研究とCRC