Yao Caiping, Raoufinia Arash, Gold Michael, Nye Jeffrey S, Ramael Steven, Padmanabhan Mukund, Walschap Yolande, Verhaeghe Tom, Zhao Qinying
Johnson and Johnson Pharmaceutical Research and Development, LLC, 1125 Trenton-Harbourton Road, PO Box 200, Titusville, NJ 08560, USA.
J Clin Pharmacol. 2005 May;45(5):519-28. doi: 10.1177/0091270005274551.
To evaluate the effect of multiple doses of memantine on the pharmacokinetics of galantamine and to assess the safety and tolerability of galantamine with adjunctive memantine treatment, an open-label, single-center, drug interaction study was conducted in 16 healthy adults. Subjects received an 8-mg dose of galantamine extended release once daily during week 1 and a 16-mg dose of galantamine extended release once daily during week 2. During weeks 3 and 4, they received a 16-mg dose of galantamine extended release once daily and a 10-mg dose of memantine twice daily, except on days 1 and 2 of week 3, when memantine was given as 10 mg once daily. The pharmacokinetic profile and parameters of galantamine at steady state were similar after administration of a 16-mg dose of galantamine once daily alone and after administration with a 10-mg dose of memantine twice daily. Galantamine 16 mg once daily with adjunctive memantine 10 mg twice daily was well tolerated and safe in healthy subjects.
为评估多剂量美金刚对加兰他敏药代动力学的影响，并评估加兰他敏联合美金刚治疗的安全性和耐受性，在16名健康成年人中开展了一项开放标签、单中心的药物相互作用研究。受试者在第1周每天服用一次8毫克的加兰他敏缓释片，在第2周每天服用一次16毫克的加兰他敏缓释片。在第3周和第4周，他们每天服用一次16毫克的加兰他敏缓释片，并每天两次服用10毫克美金刚，但在第3周的第1天和第2天，美金刚为每天服用一次10毫克。单独每天服用一次16毫克加兰他敏后以及每天两次服用10毫克美金刚后，加兰他敏稳态时的药代动力学特征和参数相似。在健康受试者中，每天一次服用16毫克加兰他敏联合每天两次服用10毫克美金刚耐受性良好且安全。
