[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.

100 Clinical Results associated with Drotaverine Hydrochloride

100 Translational Medicine associated with Drotaverine Hydrochloride

100 Patents (Medical) associated with Drotaverine Hydrochloride

127

Literatures (Medical) associated with Drotaverine Hydrochloride

12 Dec 2023·Expert Opinion on Pharmacotherapy

Pharmacotherapy for gastric and intestinal cramping pain: ‎ current and emerging therapies

Review

Author: Nikfar, Shekoufeh ; Abdollahi, Mohammad ; Mousavi, Taraneh ; Sharifnia, Mohammadhossein

INTRODUCTIONAcute gastrointestinal cramping pain (GICP) is a debilitating condition that affects many people worldwide, significantly reducing their quality of life. As such, prompt treatment is crucial.AREAS COVEREDThis article will explore relevant literature from databases such as PubMed, Scopus, Google Scholar, Cochrane Library, and Web of Science. Additionally, we searched ClinicalTrials.gov and the WHO ICTRP database for the latest clinical trials.EXPERT OPINIONConsensus dictates that antispasmodics such as hyoscine-N-butyl bromide and mebeverine should be the primary treatment for GICP. If these prove ineffective, patients can switch to an antispasmodic with a different mode of action or add acetaminophen/NSAIDs for more severe cases. Currently, several antispasmodics are undergoing clinical trials, including drotaverine, alverine, pinaverium, otilonium bromide, fenoverine, tiropramide, otilonium bromide, trimebutine, and peppermint oil. Well-designed head-to-head studies are necessary to evaluate current antispasmodics' safety, efficacy, pharmacokinetic, and pharmacoeconomics profiles. Recent studies have shown that fixed-dose combinations of antispasmodics + NSAIDs or two different antispasmodics can improve patient compliance and synergistically reduce GICP. Therefore, it is recommended that the global availability and accessibility of these products be enhanced.

01 Sep 2023·Journal of AOAC International

Computer-Aided Design of Eco-Friendly Imprinted Polymer Decorated Sensors Augmented by Self-Validated Ensemble Modeling Designs for the Quantitation of Drotaverine Hydrochloride in Dosage Form and Human Plasma.

Article

Author: Elsonbaty, Ahmed ; E Mostafa, Aziza ; Eissa, Maya S ; A Abdel Salam, Randa ; Attala, Khaled ; M Hadad, Ghada ; Abdelshakour, Mohamed A

BACKGROUNDComputationally designed molecular imprinted polymer (MIP) incorporation into electrochemical sensors has many advantages to the performance of the designed sensors. The innovative self-validated ensemble modeling (SVEM) approach is a smart machine learning-based (ML) technique that enables the design of more accurate predictive models using smaller data sets.OBJECTIVEThe novel SVEM experimental design methodology is exploited here exclusively to optimize the composition of four eco-friendly PVC membranes augmented by a computationally designed magnetic molecularly imprinted polymer to quantitatively determine drotaverine hydrochloride (DVN) in its combined dosage form and human plasma. Furthermore, the application of hybrid computational simulations such as molecular dynamics and quantum mechanical calculations (MD/QM) is a time-saving and eco-friendly provider for the tailored design of the MIP particles.METHODHere, for the first time, the predictive power of ML is assembled with computational simulations to develop four PVC-based sensors decorated by computationally designed MIP particles using four different experimental designs known as central composite, SVEM-LASSO, SVEM-FWD, and SVEM-PFWD. The pioneering AGREE approach further assessed the greenness of the analytical methods, proving their eco-friendliness.RESULTSThe proposed sensors showed decent Nernstian responses toward DVN in the range of 58.60-59.09 mV/decade with a linear quantitative range of 1 × 10-7 - 1 × 10-2 M and limits of detection in the range of 9.55 × 10-8 to 7.08 × 10-8 M. Moreover, the proposed sensors showed ultimate eco-friendliness and selectivity for their target in its combined dosage form and spiked human plasma.CONCLUSIONSThe proposed sensors were validated in accordance with International Union of Pure and Applied Chemistry (IUPAC) recommendations, proving their sensitivity and selectivity for drotaverine determination in dosage form and human plasma.HIGHLIGHTSThis work presents the first ever application of both the innovative SVEM designs and MD/QM simulations in the optimization and fabrication of drotaverine-sensitive and selective MIP-decorated PVC sensors.

16 Aug 2023·Pharmaceutics

The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations.

Article

Author: Vlad, Robert-Alexandru ; Antonoaea, Paula ; Pintea, Cezara ; Todoran, Nicoleta ; Bîrsan, Magdalena ; Chirteș, Diana-Andreea ; Ciurba, Adriana ; Rédai, Emöke Margit

The main objective of this study consists in establishing the influence of the intergranular superdisintegrant on the specific properties of drotaverine hydrochloride fast-dissolving granules (DROT-FDGs) and orodispersible tablets (DROT-ODTs). The orodispersible tablets were obtained by the compression of the FDGs and excipient mixture with an eccentric tableting machine. To develop DROT-ODTs, two types of superdisintegrant excipients in different concentrations (water-soluble soy polysaccharides (SSP) (1%, 5%) and water-insoluble soy polysaccharides-Emcosoy^® STS IP (EMCS) (1%, 3%, 5%)) were used, resulting in five formulations (D1-D5). The DROT-FDGs and the DROT-ODTs were subjected to pharmacotechnical and analytical evaluation. All the orodispersible tablets obtained respect the quality requirements in terms of friability (less than 1%), crushing strength (ranging between 52 N for D2 and 125.5 N for D3), and disintegration time (<180 s). The in vitro release of drotaverine from ODTs showed that all formulations presented amounts of active substance released greater than 85% at 10 min. The main objective, developing 30 mg DROT-ODTs for children aged between 6 and 12 years by incorporating the API in FDGs, was successfully achieved.

100 Deals associated with Drotaverine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Drotaverine Hydrochloride	A03AD02	DB06751

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Muscle Spasticity	CN	CHINOIN Pharmaceutical Co.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCLC2013	Not Applicable	Advanced Lung Adenocarcinoma	558	Gefitinib treatment	(riexuzctok) = yunumrfkcl usrabgshfq (ylyronrwjm )	Positive	30 Oct 2013
				No Gefitinib treatment	(riexuzctok) = fpjtfovfjv usrabgshfq (ylyronrwjm )
NCT00731198 (CTgov)	Phase 3	Pancreatic Diseases \| Bile Duct Diseases	650	Drotaverine hydrochloride (Experimental)	prlgbmetmr(mfqoywmfqx) = amudfrmoac eagowygwht (jozrhtvzfd, jglxyitukh - nebzwvapnf) View more	-	23 Dec 2009
				Hyoscine-N-butylbromide (Active Comparator)	prlgbmetmr(mfqoywmfqx) = tuvnrwyuln eagowygwht (jozrhtvzfd, wjqgdnkheh - ydeuoigjwf) View more
IAS2003	Not Applicable	-	1,290	ZDV -> D4T switch	ajnxqtmgcq(oxdznyzsrp) = vjvhbjsjwo ldnnhmxjec (ttcrpskbxm )	-	01 Jan 2003
				DDI <-> 3TC switch	ajnxqtmgcq(oxdznyzsrp) = tjtjxrwren ldnnhmxjec (ttcrpskbxm )

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