[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of drotaverine hydrochloride tablets (40 mg) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择Opella Healthcare为持证商的盐酸屈他维林片（商品名：NO-SPA；规格：40mg）为参比制剂，对石家庄四药有限公司生产并提供的受试制剂盐酸屈他维林片（规格：40mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂盐酸屈他维林片（规格：40mg）和参比制剂盐酸屈他维林片（商品名：NO-SPA；规格：40mg）的安全性。

[Translation]

The main purpose of the study: According to the relevant provisions of the bioequivalence test, Opella Healthcare was selected as the reference preparation for the drotaverine hydrochloride tablets (trade name: NO-SPA; specification: 40 mg), and the test preparation drotaverine hydrochloride tablets (specification: 40 mg) produced and provided by Shijiazhuang Siyao Co., Ltd. was used for the human bioequivalence test of fasting and postprandial administration. The absorption rate and degree of the drug in the test preparation were compared with the reference preparation to see whether they were within the acceptable range, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. The secondary purpose of the study: To observe the safety of oral administration of the test preparation drotaverine hydrochloride tablets (specification: 40 mg) and the reference preparation drotaverine hydrochloride tablets (trade name: NO-SPA; specification: 40 mg) to healthy volunteers.

Start Date03 Dec 2023

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20232627

/ CompletedNot Applicable

盐酸屈他维林片生物等效性试验

[Translation] Bioequivalence study of drotaverine hydrochloride 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江西亿友药业有限公司生产的盐酸屈他维林片（受试制剂，规格：40mg）和Opella Healthcare France SAS持证的盐酸屈他维林片（参比制剂，商品名：NO-SPA®，规格：40mg）后的药代动力学特点和生物等效性。次要研究目的研究盐酸屈他维林片的受试制剂（规格：40mg）和参比制剂（NO-SPA®，规格：40mg）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 single oral doses of drotaverine hydrochloride tablets (test preparation, specification: 40 mg) produced by Jiangxi Yiyou Pharmaceutical Co., Ltd. and drotaverine hydrochloride tablets (reference preparation, trade name: NO-SPA®, specification: 40 mg) certified by Opella Healthcare France SAS in healthy Chinese adult subjects under fasting and postprandial conditions. Secondary study objectives To study the safety of the test preparation (specification: 40 mg) and reference preparation (NO-SPA®, specification: 40 mg) of drotaverine hydrochloride tablets in healthy Chinese adult subjects.

Start Date28 Aug 2023

Sponsor / Collaborator

Jiangxi Yiyou Pharmaceutical Co., Ltd.

CTR20231562

/ CompletedNot Applicable

中国健康受试者空腹和餐后单次口服盐酸屈他维林片的随机、开放、两序列、两周期、双交叉设计的生物等效性试验

[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of drotaverine hydrochloride tablets in Chinese healthy volunteers after fasting or after meals

主要目的： 1.研究空腹单次口服盐酸屈他维林片受试制剂（40mg，江苏联环药业股份有限公司）与盐酸屈他维林片参比制剂（NO-SPA®，40mg，Sanofi-Aventis公司）后屈他维林在中国健康受试者体内的药代动力学行为，评价空腹口服两种制剂的生物等效性。 2.研究餐后单次口服盐酸屈他维林片受试制剂（40mg，江苏联环药业股份有限公司）与盐酸屈他维林片参比制剂（NO-SPA®，40mg，Sanofi-Aventis公司）后屈他维林在中国健康受试者体内的药代动力学行为，评价餐后口服两种制剂的生物等效性。次要目的：评价中国健康受试者单次口服盐酸屈他维林片受试制剂和参比制剂后的安全性。

[Translation]

Main objectives: 1. To study the pharmacokinetic behavior of drotaverine hydrochloride tablets (40 mg, Jiangsu Lianhuan Pharmaceutical Co., Ltd.) and the reference preparation of drotaverine hydrochloride tablets (NO-SPA®, 40 mg, Sanofi-Aventis) in healthy Chinese subjects after a single oral administration on an empty stomach, and to evaluate the bioequivalence of the two preparations after oral administration on an empty stomach. 2. To study the pharmacokinetic behavior of drotaverine hydrochloride tablets (40 mg, Jiangsu Lianhuan Pharmaceutical Co., Ltd.) and the reference preparation of drotaverine hydrochloride tablets (NO-SPA®, 40 mg, Sanofi-Aventis) in healthy Chinese subjects after a single oral administration on a empty stomach, and to evaluate the bioequivalence of the two preparations after oral administration on a empty stomach. Secondary objectives: To evaluate the safety of the test preparation and the reference preparation of drotaverine hydrochloride tablets in healthy Chinese subjects after a single oral administration on an empty stomach.

Start Date01 Jun 2023

Sponsor / Collaborator

Jiangsu Lianhuan Pharmaceutical Co., Ltd.

100 Clinical Results associated with Spasm biliary

100 Translational Medicine associated with Spasm biliary

0 Patents (Medical) associated with Spasm biliary

Literatures (Medical) associated with Spasm biliary

01 Apr 2025·International Journal of Surgery Case Reports

Complex Roux en Y double hepaticojejunostomy following a sequalae of iatrogenic bile duct injury; case report

Article

Author: Mwanga, Ally ; Rofaeil, Bishoy ; Sumbizi, Clarence ; Fidaali, Zainab ; Ismail, Allyzain ; Obwar, Arnold

INTRODUCTION AND IMPORTANCEObstructive jaundice following iatrogenic biliary injury is a rare but serious complication, often resulting from procedures such as laparoscopic cholecystectomy. It poses significant diagnostic and therapeutic challenges due to its complexity and potential for life-altering sequelae. Timely recognition and management are essential to prevent long-term morbidity. This report highlights the clinical course and successful surgical management of a complex biliary injury, underscoring the importance of advanced imaging, timing and prompt intervention.CASE PRESENTATIONA 53-year-old woman presented with a one-month history of obstructive jaundice, progressive pruritus, pale stools, and dark urine. She denied pain or systemic symptoms. Her medical history included a laparoscopic cholecystectomy six months earlier, complicated by biliary peritonitis, which necessitated an exploratory laparotomy. Imaging revealed extensive biliary disruption, including absence of the common hepatic duct and a laceration of the left hepatic duct. Surgical reconstruction was performed using a Roux-en-Y hepaticojejunostomy. Postoperatively, the patient had an uneventful recovery, with significant clinical improvement and normalization of liver biochemistry.CLINICAL DISCUSSIONIatrogenic biliary injuries, though uncommon, can result in significant morbidity. Early recognition through clinical suspicion and advanced imaging modalities is crucial for accurate diagnosis. Surgical intervention, particularly hepaticojejunostomy, remains the cornerstone of treatment for extensive biliary disruption, offering durable outcomes and resolution of symptoms.CONCLUSIONThis case underscores the importance of vigilance in diagnosing and managing complex biliary injuries. Multidisciplinary collaboration, advanced imaging, and timely surgical repair are key to achieving favorable outcomes in such challenging cases.

01 Mar 2024·iScience

Simple virus-free mouse models of COVID-19 pathologies and oral therapeutic intervention

Article

Author: Zhi, Wenbo ; Boghani, Faizan ; Van Der Eerden, Joshua ; Lopez, Aileen ; Lokeshwar, Vinata B ; Zhu, Huabin ; Klein, Kandace ; White, Joe ; Singh, Nagendra ; Aguilar, Karina ; Thangaraju, Muthusamy ; Sharma, Anuj K ; George, Michelle ; Patel, Nikhil ; Ramesh, Janavi ; Panda, Chandramukhi S ; Sarcan, Semih ; Lokeshwar, Bal L ; Bollag, Roni

The paucity of preclinical models that recapitulate COVID-19 pathology without requiring SARS-COV-2 adaptation and humanized/transgenic mice limits research into new therapeutics against the frequently emerging variants-of-concern. We developed virus-free models by C57BL/6 mice receiving oropharyngeal instillations of a SARS-COV-2 ribo-oligonucleotide common in all variants or specific to Delta/Omicron variants, concurrently with low-dose bleomycin. Mice developed COVID-19-like lung pathologies including ground-glass opacities, interstitial fibrosis, congested alveoli, and became moribund. Lung tissues from these mice and bronchoalveolar lavage and lung tissues from patients with COVID-19 showed elevated levels of hyaluronic acid (HA), HA-family members, an inflammatory signature, and immune cell infiltration. 4-methylumbelliferone (4-MU), an oral drug for biliary-spasm treatment, inhibits HA-synthesis. At the human equivalent dose, 4-MU prevented/inhibited COVID-19-like pathologies and long-term morbidity; 4-MU and metabolites accumulated in mice lungs. Therefore, these versatile SARS-COV-2 ribo-oligonucleotide oropharyngeal models recapitulate COVID-19 pathology, with HA as its critical mediator and 4-MU as a potential therapeutic for COVID-19.

01 Jan 2024·Nihon Shokakibyo Gakkai zasshi = The Japanese journal of gastro-enterology

[Gallbladder carcinosarcoma associated with pancreaticobiliary maljunction with biliary dilation:a case report].

Article

Author: Fukazawa, Atsuko ; Kaneko, Junichi ; Takinami, Masaki ; Tsuji, Atsushi ; Nishino, Masafumi ; Takahashi, Yurimi ; Niwa, Tomoyuki ; Sakaguchi, Takanori ; Suzuki, Daijiro ; Jindo, Osamu ; Tamakoshi, Hiroki ; Kosugi, Toshikatsu ; Kusama, Daisuke ; Kiuchi, Ryota ; Watahiki, Moeka ; Sasada, Yuzo ; Yamada, Takanori

A 68-year-old female patient was referred to our hospital with acute cholangitis. Computed tomography revealed common bile duct dilatation, gallbladder fundal tumor, and gallbladder wall thickening attached to the tumor. Cholangiography revealed pancreaticobiliary maljunction with biliary dilation. The patient was diagnosed with pancreaticobiliary maljunction with biliary dilation and gallbladder cancer and underwent liver S4b+5 and bile duct resection and reconstruction. Pathological results revealed that the gallbladder fundal tumor included sarcoma, and the gallbladder wall thickening had adenocarcinoma;thus, the patient was diagnosed with gallbladder carcinosarcoma.

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