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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date21 Jan 2011 |
ED-71单次给药在健康成年男性志愿者中的安全性和药代动力学研究-一项开放、随机、双剂量、双周期交叉临床试验
[Translation] Safety and pharmacokinetics of a single dose of ED-71 in healthy adult male volunteers: an open, randomized, double-dose, double-period crossover clinical trial
以健康成年男性为对象,通过2×2的交叉设计法(非盲态),对空腹单次口服ED-71制剂(0.5 μg和0.75 μg)的药代动力学进行研究,同时评价其安全性。
[Translation] Methods: The pharmacokinetics of a single oral dose of ED-71 (0.5 μg and 0.75 μg) on an empty stomach was studied in healthy adult males using a 2×2 crossover design (unblinded), and its safety was also evaluated.
以腰椎骨密度为指标、针对原发性骨质疏松症的与阿法骨化醇的对照试验
[Translation] A controlled trial with alfacalcidol for primary osteoporosis using lumbar spine bone mineral density as an indicator
以原发性骨质疏松症患者为对象,通过以阿法骨化醇为对照药的随机、双盲双模拟、平行对照试验,对ED-71的有效性和安全性进行研究。以腰椎骨密度为主要评价指标,验证ED-71相对于阿法骨化醇的优效性。
[Translation] The efficacy and safety of ED-71 were studied in patients with primary osteoporosis through a randomized, double-blind, double-dummy, parallel controlled trial with alfacalcidol as the control drug. Lumbar spine bone density was used as the main evaluation index to verify the superiority of ED-71 over alfacalcidol.
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