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MechanismGRIA2 positive allosteric modulator |
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Originator Org.- |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.IT |
First Approval Date01 Jan 1987 |
Target- |
Mechanism- |
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Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
(S)-奥拉西坦胶囊的安全耐受性、药代动力学特征及探索代谢物谱的单中心I期临床研究
[Translation] A single-center phase I clinical study on the safety and tolerability, pharmacokinetic characteristics and metabolite profile of (S)-oxiracetam capsules
主要目的 (1)评价中国健康受试者单次和多次口服(S)-奥拉西坦胶囊的安全性及耐受性。 (2)评价中国健康受试者单次和多次口服(S)-奥拉西坦胶囊的药代动力学特征。 次要目的 (1)评价(S)-奥拉西坦胶囊在中国健康受试者体内的手性转化。 (2)评价食物对(S)-奥拉西坦胶囊吸收的影响。 (3)探索(S)-奥拉西坦胶囊在中国健康受试者体内的代谢物谱。
[Translation] Primary objectives (1) To evaluate the safety and tolerability of (S)-Oxiracetam capsules after single and multiple oral administration in healthy Chinese subjects. (2) To evaluate the pharmacokinetic characteristics of (S)-Oxiracetam capsules after single and multiple oral administration in healthy Chinese subjects. Secondary objectives (1) To evaluate the chiral transformation of (S)-Oxiracetam capsules in healthy Chinese subjects. (2) To evaluate the effect of food on the absorption of (S)-Oxiracetam capsules. (3) To explore the metabolite profile of (S)-Oxiracetam capsules in healthy Chinese subjects.
100 Clinical Results associated with Chongqing Dongze Medicine Technology Development Co., Ltd.
0 Patents (Medical) associated with Chongqing Dongze Medicine Technology Development Co., Ltd.
100 Deals associated with Chongqing Dongze Medicine Technology Development Co., Ltd.
100 Translational Medicine associated with Chongqing Dongze Medicine Technology Development Co., Ltd.