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MechanismIGF-1R antagonists |
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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价马来酸甲麦角新碱注射液预防剖宫产产后出血的有效性和安全性的多中心、随机、双盲、安慰剂平行对照的III期临床试验
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of methylergonovine maleate injection in preventing postpartum hemorrhage during cesarean section
主要目的:评价马来酸甲麦角新碱注射液预防产后出血有效性。
次要目的:评价马来酸甲麦角新碱注射液预防产后出血的安全性。
[Translation] Primary objective: To evaluate the effectiveness of methylergonovine maleate injection in preventing postpartum hemorrhage.
Secondary objective: To evaluate the safety of methylergonovine maleate injection in preventing postpartum hemorrhage.
/ CompletedNot Applicable 布比卡因脂质体注射液在中国健康受试者中的单中心、随机、开放、双周期、双交叉空腹状态下的生物等效性试验
[Translation] A single-center, randomized, open-label, two-period, double-crossover bioequivalence study of bupivacaine liposome injection in Chinese healthy subjects under fasting conditions
主要目的:在空腹状态下,比较浙江博崤生物制药有限公司提供的布比卡因脂质体注射液(规格:266 mg/20 mL)与Pacira Phrumaceuticals Inc公司持证的布比卡因脂质体注射液(规格:266 mg/20 mL,商品名:Exparel®)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的:在空腹状态下,评价浙江博崤生物制药有限公司提供的布比卡因脂质体注射液(规格:266 mg/20 mL)的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of bupivacaine liposome injection (specification: 266 mg/20 mL) provided by Zhejiang Boqiao Biopharmaceutical Co., Ltd. and bupivacaine liposome injection (specification: 266 mg/20 mL, trade name: Exparel®) certified by Pacira Phrumaceuticals Inc. in healthy adults under fasting conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of bupivacaine liposome injection (specification: 266 mg/20 mL) provided by Zhejiang Boqiao Biopharmaceutical Co., Ltd. under fasting conditions.
评估马来酸甲麦角新碱注射液在中国健康女性受试者中的药代动力学研究—— 一项单中心、随机、开放的I期临床研究
[Translation] Evaluation of the pharmacokinetics of methylergonovine maleate injection in healthy Chinese female subjects: a single-center, randomized, open-label phase I clinical study
主要目的:测定在健康女性受试者中马来酸甲麦角新碱注射液单次静脉注射和肌肉注射给药后不同时间的药物浓度,评估其药代动力学特征。
次要目的:分别评价在健康女性受试者中马来酸甲麦角新碱注射液单次静脉注射和肌肉注射给药的安全性和耐受性。
[Translation] Primary objective: To determine the drug concentrations at different times after a single intravenous and intramuscular injection of methylergonovine maleate injection in healthy female subjects and to evaluate its pharmacokinetic characteristics.
Secondary objective: To evaluate the safety and tolerability of a single intravenous and intramuscular injection of methylergonovine maleate injection in healthy female subjects.
100 Clinical Results associated with Zhejiang Boxiao Biopharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhejiang Boxiao Biopharmaceutical Co., Ltd.
100 Deals associated with Zhejiang Boxiao Biopharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhejiang Boxiao Biopharmaceutical Co., Ltd.