/ CompletedNot Applicable [Translation] Bioequivalence study of flurbiprofen gel patch in healthy volunteers
考察健康受试者单次贴敷 1 贴由广东伊康纳斯生物医药科技股份有限公司提供的氟比洛芬凝胶贴膏【受试制剂 T,规格:每贴含氟比洛芬 40mg(面积 13.6cm×10.0cm,含膏量 12g)】或 Mikasa Seiyaku Co.,Ltd 生产的氟比洛芬凝胶贴膏(参比制剂 R,规格:每贴含氟比洛芬 40mg(面积 13.6cm×10.0cm,含膏量 12g)】的药代动力学特征,评价两制剂的生物等效性和安全性,同时考察两制剂的粘附性,为该受试制剂注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single application of one flurbiprofen gel patch provided by Guangdong Econas Biopharmaceuticals Co., Ltd. [test preparation T, specification: each patch contains 40 mg flurbiprofen (area 13.6 cm × 10.0 cm, paste content 12 g)] or a flurbiprofen gel patch produced by Mikasa Seiyaku Co., Ltd. (reference preparation R, specification: each patch contains 40 mg flurbiprofen (area 13.6 cm × 10.0 cm, paste content 12 g)] to healthy subjects, evaluate the bioequivalence and safety of the two preparations, and investigate the adhesion of the two preparations, so as to provide a basis for the registration application of the test preparation.
中国女性健康受试者多剂左炔诺孕酮炔雌醇透皮避孕贴后药代动力学和药效学特征的研究
[Translation] Study on the pharmacokinetic and pharmacodynamic characteristics of levonorgestrel ethinyl estradiol transdermal contraceptive patch after multiple doses in healthy Chinese female subjects
在中国女性受试者中评价左炔诺孕酮炔雌醇透皮避孕贴药代动力学及药效学,进而合理化本贴剂的规格配比及剂量, 为后期试验提供数据依据。
[Translation] To evaluate the pharmacokinetics and pharmacodynamics of the levonorgestrel ethinyl estradiol transdermal contraceptive patch in Chinese female subjects, and then rationalize the specifications, ratios and dosages of this patch to provide data basis for subsequent trials.
一项开放、单剂量研究,在健康中国女性受试者中评价左炔诺孕酮炔雌醇透皮避孕贴药代动力学
[Translation] An open-label, single-dose study evaluating the pharmacokinetics of levonorgestrel ethinylestradiol transdermal contraceptive patch in healthy Chinese female subjects
本项试验的目的是在中国女性受试者中评价左炔诺孕酮炔雌醇透皮避孕贴药代动力学,进而合理化本贴剂的规格配比及剂量, 为后期试验提供数据依据。
[Translation] The purpose of this trial is to evaluate the pharmacokinetics of the levonorgestrel ethinyl estradiol transdermal contraceptive patch in Chinese female subjects, and then to rationalize the specifications, ratio and dosage of this patch and provide data basis for subsequent trials.
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