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MechanismCGRP antagonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date14 Sep 2018 |
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MechanismVMAT2 inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date03 Apr 2017 |
一项评估 TV-44749(奥氮平缓释注射用混悬液)在中国精神分裂症患者中的安全性、耐受性和药代动力学的 I 期、单剂量、平行队列研究
[Translation] A Phase I, Single-Dose, Parallel-Cohort Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TV-44749 (Olanzapine Extended-Release Injectable Suspension) in Chinese Patients with Schizophrenia
评估皮下注射用奥氮平缓释混悬液 (TV-44749) 单次给药用于中国精神分裂症患者的安全性, 耐受性及药代动力学。
[Translation] To evaluate the safety, tolerability, and pharmacokinetics of a single dose of subcutaneous olanzapine extended-release suspension (TV-44749) in Chinese patients with schizophrenia.
一项评价 TV-44749 治疗精神分裂症成人患者的有效性和安全性的随机、双
盲、安慰剂对照研究,包括一个开放标签、长期安全性阶段
[Translation] A randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of TV-44749 in adults with schizophrenia, including an open-label, long-term safety phase
:精神分裂症是一种使人衰弱的重度精神病性障碍,其特征包括阳性和阴性症状,全
球终生发病风险约为 1%。对于大多数患者来说,这一疾病伴有需要长期使用抗精神病药
物治疗的慢性病程。不依从和不遵守长期口服药物治疗方案是精神分裂症和相关疾病治疗
中最重要的治疗问题,导致这些患者中的许多频繁复发或加重,且无法从抗精神病药物治
疗中完全获益。缓释注射用抗精神病药物可能会提高精神分裂症患者的依从性。目前,奥
氮平的口服、长效肌肉注射 (im) 和速效 im 制剂被批准用于治疗患有精神分裂症的成人。
一种用于皮下注射 (sc) 的奥氮平缓释混悬液新制剂 (TV-44749) 旨在用于治疗精神分裂
症。
[Translation] Schizophrenia is a debilitating, severe psychotic disorder characterized by both positive and negative symptoms with a global lifetime risk of approximately 1%. For most patients, the disease is associated with a chronic course requiring long-term antipsychotic treatment. Nonadherence and noncompliance with long-term oral medication regimens are the most important treatment issues in the treatment of schizophrenia and related disorders, resulting in many of these patients experiencing frequent relapses or exacerbations and failing to fully benefit from antipsychotic treatment. Extended-release injectable antipsychotics may improve adherence in patients with schizophrenia. Currently, oral, long-acting intramuscular (IM), and rapid-acting IM formulations of olanzapine are approved for the treatment of adults with schizophrenia. A new formulation of olanzapine extended-release suspension (TV-44749) for subcutaneous injection (sc) is intended for the treatment of schizophrenia.
一项评价单次给药12 mg安泰坦®片剂在健康中国受试者中的氘丁苯那嗪及其活性代谢物的药代动力学特征的开放性、单剂量研究
[Translation] An open-label, single-dose study evaluating the pharmacokinetic profile of deutetrabenazine and its active metabolite in healthy Chinese subjects after a single 12 mg dose of Antaetan® tablets
评价健康中国男性和女性受试者餐后单次口服12 mg TEV-50717片剂后TEV-50717(母体药物)及其活性氘代代谢物α-二氢丁苯那嗪(α-HTBZ)和β-二氢丁苯那嗪(β-HTBZ)(总和及单个成分)的药代动力学特征。
[Translation] To evaluate the pharmacokinetic profiles of TEV-50717 (parent drug) and its active deuterated metabolites α-dihydrotetrabenazine (α-HTBZ) and β-dihydrotetrabenazine (β-HTBZ) (total and individual components) after a single oral dose of 12 mg TEV-50717 tablets in healthy Chinese male and female subjects after a meal.
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