一项评估吸入式甲氧氟烷对健康成人受试者的安全性、耐受性和药代动力学的随机、双盲、安慰剂对照试验
[Translation] A randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of inhaled methoxyflurane in healthy adult subjects
主要目的:
评估健康中国成人受试者给予吸入式甲氧氟烷的安全性和耐受性
次要目的:
评估健康中国成人受试者给予吸入式甲氧氟烷时甲氧氟烷和氟化物的药代动力学 (PK) 特性
[Translation] Primary objective:
To evaluate the safety and tolerability of inhaled methoxyflurane in healthy Chinese adult subjects
Secondary objective:
To evaluate the pharmacokinetic (PK) properties of methoxyflurane and fluoride in healthy Chinese adult subjects when inhaled methoxyflurane is administered
中国健康男性志愿者在空腹及餐后条件下单次口服他达拉非片(20mg)的随机、开放、双周期、双交叉的生物等效性研究
[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of a single oral dose of tadalafil tablets (20 mg) in healthy Chinese male volunteers under fasting and fed conditions
以沢井制药株式会社生产的他达拉非片(规格:20mg/片)为受试制剂,按生物等效性研究的有关规定,以Lilly del Caribe, Inc.生产的他达拉非片(规格:20mg/片,商品名:希爱力®)为参比制剂,考察两种制剂的生物利用度,对受试制剂和参比制剂的生物等效性进行评价,为临床用药提供参考数据。
[Translation] Tadalafil tablets (specification: 20 mg/tablet) produced by Sawai Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence studies, tadalafil tablets (specification: 20 mg/tablet, trade name: Cialis®) produced by Lilly del Caribe, Inc. were used as the reference preparation. The bioavailability of the two preparations was investigated, and the bioequivalence of the test preparation and the reference preparation was evaluated to provide reference data for clinical drug use.
100 Clinical Results associated with Beijing Global Pharmaceutical Research Co., Ltd.
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