[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of pioglitazone-metformin tablets [each tablet contains 15 mg pioglitazone hydrochloride (calculated as pioglitazone) and 500 mg metformin hydrochloride] in Chinese healthy subjects under fasting and fed conditions

以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定海南皇隆制药股份有限公司生产的吡格列酮二甲双胍片给药后血浆中的二甲双胍和吡格列酮在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以武田テバ薬品株式会社持证生产的吡格列酮二甲双胍片【商品名：メタクト®配合錠LD，规格：15mg/500mg】为参比，评价制剂间的生物等效性，并观察吡格列酮二甲双胍片在中国健康受试者中的安全性。

[Translation]

Using Chinese healthy subjects as test subjects, a self-cross-control experimental design was adopted to determine the plasma concentrations of metformin and pioglitazone in healthy subjects after administration of pioglitazone and metformin tablets produced by Hainan Huanglong Pharmaceutical Co., Ltd. Over time, the corresponding pharmacokinetic parameters were estimated, and the pioglitazone and metformin tablets [trade name: Pioglitazone® compound tablets LD, specification: 15mg/500mg] produced by Takeda Tubo Co., Ltd. with a license were used as a reference to evaluate the differences between preparations. The bioequivalence of pioglitazone and metformin tablets was observed in Chinese healthy subjects.

Start Date28 Jul 2024

Sponsor / Collaborator

Hainan Hualon Pharmaceutical Co., Ltd.

CTR20241597 / CompletedNot Applicable

己酮可可碱缓释片在中国成年健康受试者中的一项随机、开放、空腹单次给药、两制剂、两序列、两周期交叉和餐后单次给药、两制剂、三序列、三周期交叉的生物等效性研究

[Translation] A randomized, open-label, fasting single-dose, two-dose, two-sequence, two-period crossover and fed single-dose, two-dose, three-sequence, three-period crossover bioequivalence study of pentoxifylline extended-release tablets in healthy Chinese adult subjects

主要研究目的：考察单次口服0.4g（空腹/餐后）受试制剂己酮可可碱缓释片（规格：0.4g）与参比制剂己酮可可碱缓释片（Trental？，规格：0.4g）在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价受试制剂和参比制剂单次口服0.4g（空腹/餐后）在中国成年健康受试者中的安全性。

[Translation]

Main research objectives: To investigate the relative bioavailability of the test preparation pentoxifylline sustained-release tablets (specification: 0.4g) and the reference preparation pentoxifylline sustained-release tablets (Trental?, specification: 0.4g) in healthy Chinese subjects after a single oral administration of 0.4g (fasting/after meals), analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. Secondary research objectives: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects after a single oral administration of 0.4g (fasting/after meals).

Start Date13 May 2024

Sponsor / Collaborator

Hainan Hualon Pharmaceutical Co., Ltd.

CTR20233378 / CompletedNot Applicable

富马酸伏诺拉生片在健康受试者中随机、开放、两制剂、单次给药、两周期、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 vonoprazan fumarate tablets in healthy subjects under fasting and fed conditions

主要目的：以海南皇隆制药股份有限公司研制的富马酸伏诺拉生片为受试制剂，以Takeda Pharmaceutical Company Limited持证的富马酸伏诺拉生片（商品名：沃克®）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/餐后口服富马酸伏诺拉生片受试制剂和参比制剂后的安全性。

[Translation]

Primary objective: To use the vonoprazan fumarate tablets developed by Hainan Huanglong Pharmaceutical Co., Ltd. as the test preparation and the vonoprazan fumarate tablets (trade name: Walker®) certified by Takeda Pharmaceutical Company Limited as the reference preparation, to investigate the pharmacokinetic parameters and relative bioavailability of the two preparations in the fasting and postprandial state after a single administration, and to evaluate whether the two preparations are bioequivalent. Secondary objective: To evaluate the safety of the test and reference preparations of vonoprazan fumarate tablets after a single oral administration on an empty stomach/postprandial basis in healthy Chinese subjects.

Start Date30 Oct 2023

Sponsor / Collaborator

Hainan Hualon Pharmaceutical Co., Ltd.

100 Clinical Results associated with Hainan Hualon Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Hainan Hualon Pharmaceutical Co., Ltd.

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01 Aug 2019·Pharmaceutical Research

MOF Capacitates Cyclodextrin to Mega-Load Mode for High-Efficient Delivery of Valsartan

Article

Author: Wu, Li ; Lin, Yangjing ; Zhang, Wei ; Li, Guangyu ; Wang, Caifen ; Xu, Xu ; Zhang, Xi ; Li, Jun ; Chen, Yizhi ; He, Yuanzhi ; Zhang, Jiwen ; Guo, Tao ; Zhang, Suxia

PURPOSETo investigate the mechanism of enhancing solubility and bioavailability of water-insoluble drug, valsartan (VAL), with being mega-loaded by cyclodextrin metal organic framework (CD-MOF).METHODSVAL was successfully mega-loaded into CD-MOF by magnetic agitation of VAL in ethanolic solution. Characterizations including powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), synchrotron radiation-based Fourier transform-infrared spectroscopy (SR-FTIR) ¹³C solid-state nuclear magnetic resonance spectroscopy ( ¹³C SS-NMR), nitrogen gas adsorption, and small-angle X-ray scattering (SAXS) were carried out to confirm the mechanism and incorporation behavior of VAL in CD-MOF. Ball milling process combined with molecular modeling was also used to confirm the mechanism. Improvement of bioavailability in vivo was confirmed by pharmacokinetic experiment in beagles.RESULTSAs a carrier with payload 150% higher than conventional CD complexation, CD-MOF included molecules of VAL as complexations in the chambers of (γ-CD)₂, and nanoclusters in the confined spherical cages of (γ-CD)₆ confirmed by SAXS and ¹³C SS-NMR. Ball milling combined with molecular modeling inferred that the reduced release rate of the milled CD-MOF with ultrahigh drug payload was mainly due to the partial aggregation of the VAL nanoclusters. The molecules of VAL as nanoclusters in the cages of (γ-CD)₆ are critical in dramatically improving the apparent solubility (39.5-fold) and oral bioavailability (1.9-fold) of VAL in contrast to γ-CD inclusion.CONCLUSIONSThe new understanding of drug nanoclusters in CD-MOF will help to design more efficient drug delivery systems using CD-MOF carrier with nanocavities.

01 Jan 2016·Xenobiotica; the fate of foreign compounds in biological systemsQ4 · MEDICINE

The effect of food on the pharmacokinetic properties and bioequivalence of two formulations of pitavastatin calcium in healthy Chinese male subjects.

Q4 · MEDICINE

Article

Author: Hu, Jinqing ; Zhang, Ming ; Huang, Wencan ; Qiu, Chang ; Ni, Xiaojia ; Wang, Zhanzhang ; Shang, Dewei ; Deng, Shuhua ; Yao, Zhenhong ; Wen, Yuguan ; Zhu, Xiuqing ; Lu, Haoyang

1. Pitavastatin is an effective treatment for primary hyperlipidemia and mixed dyslipidemia. The aim of the present study was to investigate the effect of food on the pharmacokinetic properties and bioequivalence of the original, branded, formulation of pitavastatin calcium and a new generic formulation in healthy Chinese male subjects under fasting and fed conditions. 2. Under fasting and fed conditions, 90% CIs of the geometric mean of generic/branded AUC0-48 h ratios were 92.2-102.4%, 93.1-104.5%, the ratios of ln(AUC0-∞) were 92.6-103.7%, 93.2-103.5%, and ln(Cmax) ratios were 90.7-110.3%, 84.7-100.8%, respectively. The generic and branded formulations were bioequivalent in terms of rate and extent of absorption under both the conditions. The average values of AUC0-48 h, AUC0-∞ and Cmax decreased noticeably following a high-fat breakfast. Values for AUC0-48 h were 87.69% and 83.7%, values for AUC0-∞ were 87.5% and 84.6%, and values for Cmax were 45.0% and 50.4% in subjects given the generic and branded preparations, respectively. The absorption of pitavastatin calcium tablets was delayed following a high-fat meal, with Tmax increasing by up to 2.43-fold. 3. Both formulations were generally well tolerated, with no serious adverse reactions reported. The newly developed generic formulation may provide a reliable alternative to the branded tablets for patients with primary hyperlipidemia or mixed dyslipidemia.

Zhongguo Yaofang

Content determination of 6 components in water-soluble vitamin freeze dried powder for injection by HPLC

Author: Yang, Dan-dan ; Ge, Tong ; Zhou, Hong-xia ; Yao, Zhen-hong ; Zheng, Chao-wu

The aim is to establish a method for simultaneous determination of 6 components in water-soluble vitamin freeze dried powder for injection.HPLC method was adopted.The determination was performed on Intersil 5μ ODS2 column with mobile phase A of 0.1% phosphoric acid solution of 0.005mol/L sodium pentanesulfonate and mobile phase B of 0.1% phosphoric acid solution of 0.005 mol/l sodium pentanesulfonate-acetonitrile(20:80, V/V, gradient elution) at the flow rate of 0.9ml/min.The detection wavelength was set at 210 nm, and column temperature was 40°C.The sample size was 20μl.The linear range was 0.2271-0.6812mg/mL for sodium L-ascorbate(r=0.9992), 0.08104-0.2431 mg/mL for nicotinamide(r=0.9998), 0.0098-0.0294 mg/mL for pyridoxine hydrochloride(r=0.9998), 0.03314-0.09942mg/mL for sodium pantothenate(r=0.9999), 0.006193-0.01858mg/mL for thiamine mononitrate(r=0.9998) and 0.009751-0.02925 mg/mL for riboflavin sodium phosphate(r=0.9998), resp.RSDs of precision, stability and repeatability tests were ≤1.60%.Average recoveries were 100.08%(RSD=1.54%, n=9), 99.70%(RSD=1.28%, n=9), 100.38%(RSD=1.13%, n=9), 100.47%(RSD=0.87%, n=9), 100.51%(RSD=0.70%, n=9) and 100.39%(RSD=0.64%, n=9).The method was specific, rapid, accurate and sensitive, and could be used for simultaneous determination of 6 components in water-soluble vitamin freeze dried powder for injection.

100 Deals associated with Hainan Hualon Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Hainan Hualon Pharmaceutical Co., Ltd.

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