[Translation] A single-center, open-label, randomized, single-dose, two-formulation, two-sequence, fasting and fed bioequivalence study of mianserin hydrochloride tablets in healthy subjects
Primary objective
To compare the differences in the extent and rate of absorption of Mianserin Hydrochloride Tablets (30 mg) produced by Shandong Jingwei Pharmaceutical Co., Ltd. and Mianserin Hydrochloride Tablets (30 mg, trade name: Tetramide®) certified by Organon Co., Ltd. in healthy adults under fasting and fed administration conditions, and to evaluate their bioequivalence.
Secondary objective
To evaluate the safety of Mianserin Hydrochloride Tablets (30 mg) produced by Shandong Jingwei Pharmaceutical Co., Ltd. and Mianserin Hydrochloride Tablets (30 mg, trade name: Tetramide®) certified by Organon Co., Ltd. in healthy adults under fasting and fed administration conditions.
[Translation] Preliminary human bioequivalence study of fluticasone propionate nebulized inhalation suspension in Chinese healthy volunteers under fasting condition
主要目的:
按有关生物等效性试验的规定,选择GlaxoSmithKline Australia Pty Ltd.为生产商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预试验,比较两种制剂在中国健康志愿者体内的药代动力学行为,评估两种制剂在空腹给药条件下生物等效的可能性。
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]
Main purpose: According to the relevant provisions of bioequivalence test, the fluticasone propionate suspension for nebulized inhalation produced by GlaxoSmithKline Australia Pty Ltd. (specification: 2ml: 0.5mg) was selected as the reference preparation. The test preparation fluticasone propionate suspension for nebulized inhalation (specification: 2ml: 0.5mg) produced and provided by Shandong Jingwei Pharmaceutical Co., Ltd. was subjected to a preliminary human bioequivalence test under fasting conditions. The pharmacokinetic behavior of the two preparations in healthy Chinese volunteers was compared to evaluate the possibility of bioequivalence of the two preparations under fasting conditions.
Secondary purpose: Observe the safety of oral inhalation of the test preparation fluticasone propionate suspension for nebulized inhalation (specification: 2ml: 0.5mg) and the reference preparation fluticasone propionate suspension for nebulized inhalation (specification: 2ml: 0.5mg) in healthy subjects.
[Translation] A randomized, open-label, two-formulation, single-dose, two-period, double-crossover bioequivalence study of beclomethasone formoterol inhalation aerosol in healthy volunteers
The main purpose of the study was to investigate the pharmacokinetics of beclomethasone formoterol inhalation aerosol (test preparation, 120 presses per bottle, each press contains 100μg beclomethasone dipropionate and 6μg formoterol fumarate) produced by Shandong Jingwei Pharmaceutical Co., Ltd. and beclomethasone formoterol inhalation aerosol (reference preparation, trade name: Qierchang®, 120 presses per bottle, each press contains 100μg beclomethasone dipropionate and 6μg formoterol fumarate) certified by Chiesi Farmaceutici SPA in healthy subjects after fasting administration, and to evaluate the bioequivalence of the two preparations.
The secondary purpose of the study was to observe the safety of the test preparation beclomethasone formoterol inhalation aerosol and the reference preparation (Qierchang®) in healthy 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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5
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
C26H26N4O5, triclinic, P1‾$\overline{1}$ (no. 2), a = 7.245(2) Å, b = 12.522(3) Å, c = 13.789(3) Å, α = 75.420(1)°, β = 79.628(1)°, γ = 83.226(1)°, V = 1,187.5(5) Å3, Z = 2, Rgt(F) = 0.0467, wRref(F2) = 0.1399, T = 298 K.
27 Aug 2024·ZEITSCHRIFT FUR KRISTALLOGRAPHIE-NEW CRYSTAL STRUCTURES
The crystal structure of (3aS, 4R, 7S, 7aR)-hexahydro-4, 7-methano-1H-isoindole-1, 3-(2H)-dione, C9H11NO2
Author: Guo, Xiao ; Cao, Xueli
Abstract:
C9H11NO2, monoclinic, P21/c (no. 14), a = 11.293(4) Å, b = 6.998(3) Å, c = 10.932(4) Å, β = 104.175(7)°, V = 837.6(5) Å3, Z = 4, Rgt(F) = 0.0578, wRref(F2) = 0.1330, T = 296 K.
Drugs and Clinic
Single crystal culture and structure characterization of vortioxetine DL-lactate
Author: Wang Yan-yan ; Cao Xue-li ; Tian Run-yu ; Guo Xiao ; Yan Yu-chao
Objective To prepare single crystal of vortioxetine DL-lactate, and investigate the structure characterization.Methods Evaporation method was used to grow single crystals of vortioxetine DL-lactate, which were then characterized using thermal gravimetric analyzer(TGA), differential scanning calorimetry(DSC), Fourier transform IR spectrometer(IR), powder X-ray diffraction(PXRD), and single X-ray diffraction(SXRD).Results Single colorless block crystal of vortioxetine DL-lactate form βcould be obtained through acetonitrile evaporationDSC graph and PXRD spectrum was in good agreement with data reported in literatures.SXRD results showed that the unit stoichiometric of vortioxetine DL-lactate was C21 H28 N2 O3 S, and the relative mol. mass was 388.51, and crystal d. was 1.246 g/cm3.The unit cell belonged to a monoclinic system, and the space group was P21/c.Conclusion Crystal structure of vortioxetine DL-lactate is characterized by single X-ray diffraction, which provides a basis for the further development of vortioxetine DL-lactate.
100 Deals associated with Jewim Pharmaceutical (Shandong) Co., Ltd
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100 Translational Medicine associated with Jewim Pharmaceutical (Shandong) Co., Ltd
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