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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date14 Apr 2020 |
/ Active, not recruitingPhase 3 无水甜菜碱散剂治疗同型半胱氨酸血症的Ⅲ期验证性临床试验
[Translation] Phase III confirmatory clinical trial of anhydrous betaine powder in the treatment of homocystinemia
主要研究目的
治疗第16周末血Hcy较基线的变化值。
次要研究目的
(1)治疗第2、4、8周末血Hcy较基线的变化值;
(2)治疗第2、4、8、16周末血Hcy值;
(3)治疗第2、4、8、16周末有效率。
(4)与基线(访视1)相比,治疗第2、4、8、16周末临床症状的变化情况。
[Translation] Primary study objectives: Changes in blood Hcy compared to baseline at the end of the 16th week of treatment. Secondary study objectives: (1) Changes in blood Hcy compared to baseline at the end of the 2nd, 4th, and 8th week of treatment; (2) Blood Hcy values at the end of the 2nd, 4th, 8th, and 16th week of treatment; (3) Effectiveness at the end of the 2nd, 4th, 8th, and 16th week of treatment. (4) Changes in clinical symptoms at the end of the 2nd, 4th, 8th, and 16th week of treatment compared to baseline (Visit 1).
/ CompletedNot Applicable [Translation] Equivalence test of enteric-coated aspirin tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服阿司匹林肠溶片受试制剂(规格:100mg,申办者:黑龙江省林宝药业有限责任公司)和参比制剂(商品名:拜阿司匹灵®,规格:100mg,持证商:Bayer S.p.A.)后的药代动力学特点和生物等效性。
次要研究目的
研究阿司匹林肠溶片受试制剂(规格:100mg)和参比制剂(商品名:拜阿司匹灵®,规格:100mg)在中国健康成年受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of aspirin enteric-coated tablets (specification: 100 mg, applicant: Heilongjiang Linbao Pharmaceutical Co., Ltd.) and reference preparation (trade name: Bayer Aspirin®, specification: 100 mg, licensee: Bayer S.p.A.) after a single oral dose in healthy Chinese adult subjects under fasting and postprandial conditions.
Secondary study objectives
To study the safety of aspirin enteric-coated tablets (specification: 100 mg) and reference preparation (trade name: Bayer Aspirin®, specification: 100 mg) in healthy Chinese adult subjects.
/ TerminatedNot Applicable [Translation] Equivalence test of enteric-coated aspirin tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服阿司匹林肠溶片受试制剂(规格:100mg,申办者:黑龙江省林宝药业有限责任公司)和参比制剂(商品名:拜阿司匹灵®,规格:100mg,持证商:Bayer S.p.A.)后的药代动力学特点和生物等效性。
次要研究目的
研究阿司匹林肠溶片受试制剂(规格:100mg)和参比制剂(商品名:拜阿司匹灵®,规格:100mg)在中国健康成年受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of aspirin enteric-coated tablets (specification: 100 mg, applicant: Heilongjiang Linbao Pharmaceutical Co., Ltd.) and reference preparation (trade name: Bayer Aspirin®, specification: 100 mg, licensee: Bayer S.p.A.) after a single oral dose in healthy Chinese adult subjects under fasting and postprandial conditions.
Secondary study objectives
To study the safety of aspirin enteric-coated tablets (specification: 100 mg) and reference preparation (trade name: Bayer Aspirin®, specification: 100 mg) in healthy Chinese adult subjects.
100 Clinical Results associated with Heilongjiang Linbao Pharmaceutical Co., Ltd
0 Patents (Medical) associated with Heilongjiang Linbao Pharmaceutical Co., Ltd
100 Deals associated with Heilongjiang Linbao Pharmaceutical Co., Ltd
100 Translational Medicine associated with Heilongjiang Linbao Pharmaceutical Co., Ltd