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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Canada |
First Approval Date31 Dec 1976 |
多中心、随机、双盲、安慰剂对照评价雌二醇透皮喷雾剂治疗中国绝经后或卵巢功能早衰女性血管舒缩症状的有效性和安全性的Ⅲ期研究
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of estradiol transdermal spray in the treatment of vasomotor symptoms in Chinese postmenopausal women or women with premature ovarian failure
评价雌二醇透皮喷雾剂每日1 喷、2 喷或 3 喷治疗绝经相关中重度血管舒缩症状(潮热)的有效性和安全性。
[Translation] To evaluate the effectiveness and safety of estradiol transdermal spray once, twice or three times daily for the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopause.
一项在中国健康绝经后女性受试者中评价雌二醇透皮喷雾剂多次给药的单中心、开放的药代动力学和安全性研究
[Translation] A single-center, open-label pharmacokinetic and safety study evaluating multiple-dose estradiol transdermal spray in healthy Chinese postmenopausal women
1) 评价中国健康绝经后女性每天给予 1.7% 雌二醇透皮喷雾剂1喷、 2喷或3喷连续10天达稳态后,雌二醇的人体PK特征
2) 评价中国健康绝经后女性多次给予雌二醇透皮喷雾剂后的安全性
[Translation] 1) To evaluate the human PK characteristics of estradiol in healthy Chinese postmenopausal women after daily administration of 1.7% estradiol transdermal spray 1, 2 or 3 sprays for 10 consecutive days to achieve steady state
2) To evaluate the safety of estradiol transdermal spray in healthy Chinese postmenopausal women after multiple administrations
/ CompletedNot Applicable 去氧孕烯炔雌醇片在健康育龄女性受试者中随机开放、单剂量、两周期双交叉空腹和高脂餐后的生物等效性试验
[Translation] A randomized, open-label, single-dose, two-cycle, double-crossover bioequivalence study of desogestrel ethinyl estradiol tablets in healthy female subjects of childbearing age after fasting and high-fat meal
预试验:健康育龄女性受试者高脂餐后交叉单次口服两种制剂,测定血药浓度,根据Tmax等参数优化采样时间,为高脂餐后正式试验方案优化提供依据。正式试验:主要研究目的:健康育龄女性受试者空腹和高脂餐后交叉单次口服两种制剂,评价两种制剂在空腹和高脂餐后状态下是否生物等效。次要研究目的:观察受试者的安全性。
[Translation] Preliminary study: healthy female subjects of childbearing age took two preparations orally in a single dose after a high-fat meal, measured blood drug concentration, optimized sampling time according to parameters such as Tmax, and provided a basis for optimizing the formal test plan after a high-fat meal. Formal study: Main research purpose: healthy female subjects of childbearing age took two preparations orally in a single dose after fasting and after a high-fat meal, and evaluated whether the two preparations were bioequivalent in the fasting and high-fat meal states. Secondary research purpose: observe the safety of the subjects.
100 Clinical Results associated with Jarui Pharmaceutical (China) Co., Ltd.
0 Patents (Medical) associated with Jarui Pharmaceutical (China) Co., Ltd.
100 Deals associated with Jarui Pharmaceutical (China) Co., Ltd.
100 Translational Medicine associated with Jarui Pharmaceutical (China) Co., Ltd.