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MechanismSodium channels blockers |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date29 Aug 2008 |
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MechanismD2 receptor agonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date15 Feb 2006 |
一项开放式、单剂量、评价拉考沙胺片在健康中国男性及女性受试者的药物代谢动力学及安全耐受性的研究
[Translation] An open-label, single-dose study to evaluate the pharmacokinetics and safety and tolerability of lacosamide tablets in healthy Chinese male and female subjects
主要目的是研究对健康的中国受试者进行拉考沙胺单剂量口服给药后的PK特性。 次要目的是记录健康的中国受试者接受拉考沙胺单剂量口服给药的安全性和耐受性。
[Translation] The primary objective was to investigate the PK properties of lacosamide after a single oral dose in healthy Chinese subjects. The secondary objective was to document the safety and tolerability of lacosamide in healthy Chinese subjects after a single oral dose.
扩展性研究评价作为添加治疗用于日本和中国部分性癫痫成人患者的安全性和有效性研究
[Translation] An extension study evaluating the safety and efficacy of add-on therapy in adults with partial-onset epilepsy in Japan and China
评估LCM的长期安全性、耐受性及有效性;为先前参加过EP0008的受试者提供一个继续接受LCM治疗的机会
[Translation] To evaluate the long-term safety, tolerability and efficacy of LCM; to provide subjects who previously participated in EP0008 with an opportunity to continue receiving LCM treatment
评价拉考沙胺作为联合治疗用于部分性癫痫成人患者(伴或不伴继发性全面性发作)的有效性和安全性研究III期
[Translation] Phase III study evaluating the efficacy and safety of lacosamide as combination therapy in adults with partial-onset epilepsy (with or without secondarily generalized seizures)
评估LCM合并1到3种AED(s)添加治疗(伴或不伴VNS)目前具有不可控癫痫部分性发作对日本和中国受试者(伴或不伴继发性全面性发作)的有效性。评估LCM的安全性及耐受性,LCM有效性及安全性与剂量的关系及稳态时的血药浓度。
[Translation] To evaluate the efficacy of LCM combined with 1 to 3 AED(s) as add-on therapy (with or without VNS) in Japanese and Chinese subjects with currently uncontrollable partial-onset seizures (with or without secondarily generalized seizures). To evaluate the safety and tolerability of LCM, the relationship between the efficacy and safety of LCM and the dose, and the plasma concentration at steady state.
100 Clinical Results associated with Schwarz Pharma Produktions GmbH
0 Patents (Medical) associated with Schwarz Pharma Produktions GmbH
100 Deals associated with Schwarz Pharma Produktions GmbH
100 Translational Medicine associated with Schwarz Pharma Produktions GmbH