[Translation] A randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence bioequivalence study of methylprednisolone tablets in healthy subjects under fed conditions

主要目的：以武汉九珑人福药业有限责任公司生产的甲泼尼龙片为受试制剂，按生物等效性试验的有关规定，与Pfizer Italia Srl生产的甲泼尼龙片（商品名：美卓乐®，参比制剂）对比在健康人体内的吸收速度及吸收程度，考察两制剂的人体生物等效性。次要目的：观察受试制剂甲泼尼龙片和参比制剂甲泼尼龙片（美卓乐®）在健康受试者中的安全性。

[Translation]

Main purpose: To compare the absorption rate and extent of methylprednisolone tablets produced by Wuhan Jiulong Renfu Pharmaceutical Co., Ltd. with methylprednisolone tablets (trade name: Medrol®, reference preparation) produced by Pfizer Italia Srl in healthy human bodies according to the relevant provisions of bioequivalence test, and to investigate the bioequivalence of the two preparations in humans. Secondary purpose: To observe the safety of the test preparation methylprednisolone tablets and the reference preparation methylprednisolone tablets (Metrol®) in healthy subjects.

Start Date23 Apr 2024

Sponsor / Collaborator

Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.

CTR20240788

/ CompletedNot Applicable

戊酸雌二醇片在中国健康绝经后女性参与者中单中心、随机、开放、两周期、自身交叉、单次给药的空腹和餐后状态下生物等效性研究

[Translation] A single-center, randomized, open-label, two-period, self-crossover, single-dose bioequivalence study of estradiol valerate tablets in healthy Chinese postmenopausal female participants under fasting and fed conditions

主要目的：考察空腹及餐后状态下单次口服受试制剂戊酸雌二醇片（规格：1 mg/片，武汉九珑人福药业有限责任公司生产）与参比制剂戊酸雌二醇片（补佳乐®，规格：1 mg/片；Jenapharm GmbH & Co. KG持证）在中国健康绝经后女性参与者体内的药代动力学特征，评价空腹及餐后状态口服两种制剂的生物等效性。次要目的：考察受试制剂戊酸雌二醇片（规格：1 mg/片）和参比制剂戊酸雌二醇片（补佳乐®，规格：1 mg/片）在中国健康绝经后女性参与者中的安全性。

[Translation]

Primary objective: To investigate the pharmacokinetic characteristics of the test preparation estradiol valerate tablets (specification: 1 mg/tablet, produced by Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.) and the reference preparation estradiol valerate tablets (Progynova®, specification: 1 mg/tablet; certified by Jenapharm GmbH & Co. KG) in healthy Chinese postmenopausal female participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary objective: To investigate the safety of the test preparation estradiol valerate tablets (specification: 1 mg/tablet) and the reference preparation estradiol valerate tablets (Progynova®, specification: 1 mg/tablet) in healthy Chinese postmenopausal female participants.

Start Date03 Apr 2024

Sponsor / Collaborator

Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.

CTR20240048

/ CompletedNot Applicable

布洛芬混悬液在健康受试者中随机、开放、两制剂、单次给药、双周期、双交叉空腹和餐后状态下的生物等效性试验

[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of ibuprofen suspension in healthy subjects under fasting and fed conditions

主要目的：以武汉九珑医药有限责任公司持证（武汉人福药业有限责任公司生产）的布洛芬混悬液为受试制剂，以上海强生制药有限公司生产的布洛芬混悬液（商品名：美林®）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。次要目的：评价中国健康受试者单次空腹/餐后口服布洛芬混悬液受试制剂和参比制剂后的安全性。

[Translation]

Primary objective: Using the ibuprofen suspension licensed by Wuhan Jiulong Pharmaceutical Co., Ltd. (produced by Wuhan Renfu Pharmaceutical Co., Ltd.) as the test preparation and the ibuprofen suspension (trade name: Meilin®) produced by Shanghai Johnson Pharmaceutical Co., Ltd. as the reference preparation, the pharmacokinetic parameters and relative bioavailability of the two preparations after a single administration in the fasting and postprandial state were investigated to evaluate whether the two preparations are bioequivalent. Secondary objective: To evaluate the safety of the ibuprofen suspension test preparation and reference preparation after a single oral administration in fasting/postprandial state in healthy Chinese subjects.

Start Date20 Feb 2024

Sponsor / Collaborator

Wuhan Jiulong Pharmaceutical Co., Ltd.

100 Clinical Results associated with Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

01 Jun 2024·International Journal of Biological Macromolecules

Fabrication of chitosan-based emulsion as an adjuvant to enhance nasal mucosal immune responses

Article

Author: Li, Sheng ; Liu, Shilin ; Zhang, Yangyang ; Li, Yan ; Hu, Xianwen ; Li, Donghui ; Li, Wenbo

Nasal vaccine is a non-invasive vaccine that activates systemic and mucosal immunity in the presence of an adjuvant, thereby enhancing immune function. In this work, chitosan/oligochitosan/tween 80 (CS-COS-T80) co-stabilized emulsion was designed and further used as the nasal adjuvant. CS-COS-T80 emulsion exhibited outstanding stability under pH 6-8 with uniformly dispersed droplets and nano-scale particle size (<0.25 μm), and maintained stable at 4 °C for 150-day storage. Addition of model antigen ovalbumin (OVA) had no effect on the stability of CS-COS-T80 emulsion. In vivo nasal immunity indicated that CS-COS-T80 emulsion prolonged the retention time of OVA in the nasal cavity (from 4 to 8 h to >12 h), as compared to T80-emulsion. CS-COS-T80 emulsion produced a stronger mucosal immune response to OVA, with secretory IgA levels 5-fold and 2-fold higher than those of bare OVA and commercial adjuvant MF59, respectively. Compared to MF59, CS-COS-T80 induced a stronger humoral immune response and a mixed Th1/Th2 immune response of OVA after immunization. Furthermore, in the presence of CS-COS-T80 emulsion, the secretion of IL-4 and IFN-γ and the activation of splenocyte memory T-cell differentiation increased from 173.98 to 210.21 pg/mL and from 75.46 to 104.01 pg/mL, respectively. Therefore, CS-COS-T80 emulsion may serve as a promising adjuvant platform.

01 Mar 2023·Journal of Colloid and Interface Science

Water-in-water emulsion stabilized by cellulose nanocrystals and their high enrichment effect on probiotic bacteria

Article

Author: Li, Bin ; Zhang, Yangyang ; Zhou, Chaoyi ; Li, Yan ; Xie, Yunxiao ; Liu, Shilin

HYPOTHESISThe effect of the molecular weight and polymer concentration on the partition behavior of aqueous two-phase systems (ATPs) is significant for constructing water-in-water (W/W) emulsions. Hence, a long-term stable W/W emulsion system might be obtained through selecting the appropriate stabilizer and component phases, which could be a possible carrier for probiotics.EXPERIMENTSCompared with the reported molecular weight difference between polyethylene oxide (PEO) and dextran (DEX) systems, PEO and dextran with lower molecular weight had been used for constructing the water in water (W/W) emulsion system. The W/W emulsions were stabilized using cellulose nanocrystals (CNCs), and the potential application of the W/W emulsion for the encapsulation of Lactobacillus was explored.FINDINGSEmulsion stability exhibited a "dose-effect" relationship with the CNCs concentration and was decreased with the increase of the DEX concentration. The emulsion phase separation rate was increased with increasing ionic strength and temperature. Both Lactobacillus Plantarum and Lactobacillus helveticus were highly inclined to the DEX phase, and the emulsion droplets were deformed and aggregated when the encapsulation amount was increased. This long-term stability would provide a promising approach for designing high-density culture and fermentation of probiotics.

Jingxi Shiyou Huagong Jinzhan

Analysis on influence factors affecting quality indexes of span 80

Author: Zhang, Yangyang ; Li, Juan ; Hu, Ping ; Xiao, Guanglin

Span 80 was prepared in a combined process of etherification and esterification in succession, and the effects of material ratio, reaction temperature, and reaction time on several important indexes of Span 80 like acid value, hydroxyl value, saponification value and iodine value, etc. were studied.According to the results of study, the acid value of product is on-specification when the molar ratio of dehydrated sorbitan to oleic acid is 1:(1.2 - 1.4).When the reaction temperature is 200°C and the reaction time is 6 h, the hydroxyl value decreases gradually as the content of oleic acid increases as the material ratio is increased from 1:1.2 to 1:1.4.The iodine value is off specification when com. grade oleic acid is used as the material, and is on-specification when imported vegetable oil acid is used.

100 Deals associated with Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

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