Bioequivalence of Rebamipide Granules and Tablets in Healthy Adult Male Volunteers

被引:0
|
作者
Setsuo Hasegawa
Hisakuni Sekino
Osamu Matsuoka
Kazunori Saito
Hisayuki Sekino
Aki Morikawa
Kaya Uchida
Masami Koike
Junichi Azuma
机构
[1] Sekino Clinical Pharmacology Clinic,Nishiwaki Laboratory, Bioassay Division
[2] Japan Clinical Laboratories,Department of Bioavailability Research, Formulation Research Institute, Therapeutic Application Development Group, Pharmaceutical Product Group, Pharmaceutical Marketing Division, Tokyo Branch
[3] Inc.,Clinical Evaluation of Medicines and Therapeutics, Graduate School of Pharmaceutical Sciences
[4] Otsuka Pharmaceutical Co.,undefined
[5] Ltd,undefined
[6] Osaka University,undefined
来源
关键词
Gastritis; Gastric Ulcer; Multiple Reaction Monitoring; Granule Formulation; Bioequivalence Study;
D O I
暂无
中图分类号
学科分类号
摘要
Objective: Rebamipide tablets, which are used in the treatment of patients with gastric ulcers or gastritis, can be difficult to administer in subjects with reduced swallowing ability or impaired swallowing. The granule formulation may be more easily administered in these patients. The bioequivalence between rebamipide granules (20%/0.5g) and tablets (100mg) was determined in healthy male adult volunteers, in accordance with the Partially Revised Guidelines for Bioequivalence Studies of Generic Products.
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页码:771 / 779
页数:8
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