Clinical Trials associated with Jewim Pharmaceutical (Shandong) Co., Ltd
CTR20253816
/ CompletedNot Applicable
丙酸氟替卡松雾化吸入用混悬液在中国健康志愿者中空腹状态下的人体生物等效性试验
[Translation] Bioequivalence study of fluticasone propionate nebulized inhalation suspension in Chinese healthy volunteers under fasting condition
要目的:依据生物等效性试验的相关规定,选择生产商GlaxoSmithKline Australia Pty Ltd.生产的丙酸氟替卡松雾化吸入用混悬液(规格:2ml:0.5mg)为参比制剂,对山东京卫制药有限公司生产并提供的受试制剂丙酸氟替卡松雾化吸入用混悬液(规格:2ml:0.5mg)进行空腹给药条件下的人体生物等效性试验,比较受试制剂与参比制剂的药代动力学特征,评价两种制剂在空腹给药条件下的生物等效性。 次要目的:观察健康受试者经口吸入受试制剂丙酸氟替卡松雾化吸入用混悬液(规格:2ml:0.5mg)和参比制剂丙酸氟替卡松雾化吸入用混悬液(规格:2ml:0.5mg)的安全性。
[Translation]
Primary objective: Based on the relevant regulations for bioequivalence studies, a fluticasone propionate suspension for nebulized inhalation (2 ml, 0.5 mg) manufactured by GlaxoSmithKline Australia Pty Ltd. was selected as the reference preparation. A fasting bioequivalence study was conducted on the test preparation, fluticasone propionate suspension for nebulized inhalation (2 ml, 0.5 mg), manufactured and provided by Shandong Jingwei Pharmaceutical Co., Ltd. The pharmacokinetic characteristics of the test preparation and the reference preparation were compared, and the bioequivalence of the two preparations under fasting conditions was evaluated. Secondary objective: To observe the safety of oral inhalation of the test preparation, fluticasone propionate suspension for nebulized inhalation (2 ml, 0.5 mg), and the reference preparation, fluticasone propionate suspension for nebulized inhalation (2 ml, 0.5 mg), in healthy volunteers.
[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of entacapone dopaminergic tablets (II) in healthy Chinese volunteers after meal administration
The main purpose of this study was to conduct a postprandial bioequivalence study on the entacapone bidopa tablets (II) (trade name: Stalevo®; strength: levodopa 100 mg, carbidopa 25 mg, and entacapone 200 mg) produced and provided by Shandong Jingwei Pharmaceutical Co., Ltd. in accordance with the relevant bioequivalence test regulations. The study aimed to compare the absorption rate and extent of the drug in the test preparation with those of the reference preparation to determine whether they were within an acceptable range, and to evaluate the bioequivalence of the two preparations under postprandial administration conditions. Secondary study objective: To observe the safety of oral administration of the test preparation Entacapone Bidopa Tablets (II) (specifications: levodopa 100 mg, carbidopa 25 mg and entacapone 200 mg) and the reference preparation Entacapone Bidopa Tablets (II) (trade name: Stalevo®; specifications: levodopa 100 mg, carbidopa 25 mg and entacapone 200 mg) in healthy subjects.
Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of melogabalin besylate tablets (specification: 15 mg, applicant: Shandong Jingwei Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Tarlige®, specification: 15 mg, licensee: Daiichi Sankyo Co., Ltd.) after a single oral dose in healthy Chinese adult subjects under fasting and postprandial conditions.
Secondary study objectives
To study the safety of the test formulation of melogabalin besylate tablets (specification: 15 mg) and the reference formulation (trade name: Tarlige®, specification: 15 mg) in healthy Chinese adult subjects.
100 Clinical Results associated with Jewim Pharmaceutical (Shandong) Co., Ltd
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0 Patents (Medical) associated with Jewim Pharmaceutical (Shandong) Co., Ltd
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Literatures (Medical) associated with Jewim Pharmaceutical (Shandong) Co., Ltd
28 Oct 2024·ZEITSCHRIFT FUR KRISTALLOGRAPHIE-NEW CRYSTAL STRUCTURES
The crystal structure of (Z)-3′-(2-(1-(3,4-dimethyl-phenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene)hydrazinyl)-2′-hydroxy-[1,1′-biphenyl]-3-carboxylicacid ─ methanol (1/1), C26H26N4O5
The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3
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