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主要研究目的研究空腹和餐后状态下单次口服受试制剂盐酸格拉司琼片（规格：1 mg，由宁波美诺华天康药业有限公司生产，杭州和泽坤元药业有限公司提供）与参比制剂盐酸格拉司琼片（Kytril®，规格：1 mg；Atnahs Pharma Netherlands B.V.持证，杭州和泽坤元药业有限公司提供）在健康成年受试者体内的药代动力学行为，评价空腹和餐后状态口服两种制剂的生物等效性。次要研究目的研究受试制剂盐酸格拉司琼片和参比制剂盐酸格拉司琼片（Kytril®）在健康成年受试者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetic behavior of the test preparation granisetron hydrochloride tablets (specification: 1 mg, produced by Ningbo Menova Tiankang Pharmaceutical Co., Ltd., provided by Hangzhou Heze Kunyuan Pharmaceutical Co., Ltd.) and the reference preparation granisetron hydrochloride tablets (Kytril®, specification: 1 mg; licensed by Atnahs Pharma Netherlands B.V., provided by Hangzhou Heze Kunyuan Pharmaceutical Co., Ltd.) in healthy adult subjects after single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations in fasting and fed state. Secondary study objectives To study the safety of the test preparation granisetron hydrochloride tablets and the reference preparation granisetron hydrochloride tablets (Kytril®) in healthy adult subjects.

Start Date01 Sep 2022

Sponsor / Collaborator

Hangzhou Hezekunyuan Pharmaceutical Co., Ltd.

CTR20221953

/ CompletedNot Applicable

盐酸格拉司琼片（1 mg）在健康人体内三周期参比制剂部分重复餐后生物等效性研究

[Translation] A three-cycle repeated-meal bioequivalence study of granisetron hydrochloride tablets (1 mg) with a reference formulation in healthy volunteers

主要目的：本研究以福安药业集团宁波天衡制药有限公司研制的盐酸格拉司琼片（规格：1 mg）为受试制剂，按生物等效性研究的有关规定，以Waymade Plc生产的盐酸格拉司琼片（商品名：Kytril®，规格：1 mg）为参比制剂，评估受试制剂和参比制剂餐后条件下给药后的生物等效性。次要目的：观察受试制剂盐酸格拉司琼片和参比制剂盐酸格拉司琼片（Kytril®）在健康受试者中的安全性。

[Translation]

Primary objective: This study used granisetron hydrochloride tablets (specification: 1 mg) developed by Ningbo Tianheng Pharmaceutical Co., Ltd. of Fu'an Pharmaceutical Group as the test preparation, and granisetron hydrochloride tablets (trade name: Kytril®, specification: 1 mg) produced by Waymade Plc as the reference preparation according to the relevant regulations of bioequivalence studies to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fed conditions. Secondary objective: To observe the safety of the test preparation granisetron hydrochloride tablets and the reference preparation granisetron hydrochloride tablets (Kytril®) in healthy subjects.

Start Date22 Aug 2022

Sponsor / Collaborator

Ningbo Team Pharm Co. Ltd.

NCT05314257

/ Unknown statusPhase 2/3IIT

Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section: A Randomized Clinical Trial

Cardiac disease in pregnancy is a high-risk condition and a major cause of maternal mortality and morbidity. Although direct or immediate death due to cardiovascular disease is rare, it is an important indirect cause of maternal death worldwide, with an attributable rate of two deaths per 100,000 pregnancies. Cardiovascular physiological changes during pregnancy impose an additional load on the cardiovascular system of women with underlying heart disease which increases morbidity and mortality during pregnancy and at the time of delivery. Among cardiac diseases, Rheumatic Heart Disease is the commonest cardiac disease complicating pregnancy.

Start Date01 Apr 2022

Sponsor / Collaborator

Assiut University

100 Clinical Results associated with Granisetron Hydrochloride

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100 Translational Medicine associated with Granisetron Hydrochloride

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100 Patents (Medical) associated with Granisetron Hydrochloride

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272

Literatures (Medical) associated with Granisetron Hydrochloride

03 Jul 2024·Drug and Chemical Toxicology

Effects of taxifolin on tramadol-induced oxidative and inflammatory liver injury in rats: an experimental study

Article

Author: Çoban, Taha Abdulkadir ; Kuyrukluyıldız, Ufuk ; Mokhtare, Behzad ; Subaşı, Faruk ; Ölmeztürk Karakurt, Tülay Ceren ; Eren, Nurhan ; Süleyman, Halis

In this experimental study we aimed to investigate the biochemical and histopathological effects of concomitantly administered taxifolin on tramadol-induced liver damage in rats. The rats were divided into three groups; control group (CG), tramadol alone (TRG), and taxifolin + tramadol given (TTRG) groups. Malondialdehyde (MDA), total glutathione (tGSH), total oxidant status (TOS), total antioxidant status (TAS), nuclear factor-kappa beta (NF-kB), tumor necrosis factor-α (TNF-α), and interleukin-1β (IL-1β) levels were measured in liver tissues. Liver tissues were also examined histopathologically. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities were determined in blood samples. In tissue analyses, determinants of oxidative stress and inflammation, all were significantly higher in the TRG group compared with the control and TTRG groups. In the TTRG group, all oxidative stress and inflammation markers were significantly lower than in the TRG group. In addition, there was not any significant difference between the control and TTRG groups regarding the TOS and TAS status. Serum liver enzymes were also significantly higher in the TRG group than in the other two groups. In histopathological examinations, the control group had a normal histological appearance. Degenerative-necrotic hepatocytes and hemorrhage, which were seen at a severe level in the TRG group, were found to be moderate in the treated TTRG group. In addition, mononuclear cell infiltrations were found to be severe in the TRG group and mild in the treated TTRG group. Finally it was concluded that Taxifolin alleviated the toxic effects of tramadol on the liver including the histopathological and biochemical changes as well as the oxidative damage.

01 Jul 2024·Annals of Surgical Oncology

Prognosis of a Heterogeneous TRG Pathological Response to Neoadjuvant Chemotherapy in Patients who Undergo Resection for Colorectal Liver Metastases

Review

Author: Charlotte, Frederic ; Laroche, Sophie ; Lim, Chetana ; Scatton, Olivier ; Bachet, Jean-Baptiste ; Fuks, David ; Goumard, Claire

BACKGROUNDOptimal management of colorectal liver metastasis (CRLM) is based on a combination of chemotherapy and surgical resection. The tumor regression grade (TRG) score is a histological scoring system to evaluate response to chemotherapy. The prognosis of a heterogeneous response in cases of multiple metastases has not been evaluated according to the TRG score.PATIENTS AND METHODSAll patients who underwent liver resection for multiple CRLM after neoadjuvant chemotherapy in two tertiary centers from January 2015 to April 2019 were retrospectively included. Oncological characteristics and outcome between TRG 1-2-3 (good response group), TRG 4-5 (poor response group) and heterogeneous TRG (good and poor TRG among different lesions within the same patient) groups were compared.RESULTSAmong the 327 patients included, 134 (41.0%) had good response (TRG 1-2-3), 120 (36.7%) had poor response (TRG 4-5), and 73 (22.3%) had heterogeneous response. The type and number of cycles of chemotherapy, k-Ras mutational status, and tumor number or size did not differ between the three groups. Use of irinotecan-based and anti-VEGF neoadjuvant therapy was associated with better TRG response [irinotecan-based: hazard ratio (OR) = 1.744; p = 0.045; anti-VEGF neoadjuvant therapy: 2.054; p = 0.005). Overall survival (OS) was higher in the 1-2-3 TRG group than in the heterogeneous TRG group (2-year OS = 81.3% vs. 60.3%, respectively; p = 0.003) and the 4-5 TRG group (2-year OS = 81.3% vs. 55.0%, respectively; p = 0.012) and similar between the heterogeneous and 4-5 TRG groups.CONCLUSIONSThe proportion of heterogeneous pathological response according to TRG is 22.3%, and the prognosis is comparable to that of poor pathological response.

01 Jun 2024·Journal of Gastrointestinal Cancer

Treatment Response to Neoadjuvant Therapy in Squamous Esophageal Cancer—Correlation Between Metabolic Response and Histopathology

Article

Author: Pawar, Akash ; Niyogi, Devayani ; Tiwari, Virendra Kumar ; Sabita, Jiwnani ; Kaderi, Abdeali Saif Arif

PURPOSEEsophageal cancer is among the leading causes of cancer-related mortality worldwide. Patients presenting with localized and loco-regionally advanced cancer without distant metastases have reasonable survival with multimodality management. Adequate and comprehensive staging is the backbone for proper selection of patients fit for curative treatment. Positron emission tomography (PET) in combination with contrast-enhanced computed tomography (CECT) is utilized as the standard staging modality. Multimodality treatment has been able to achieve evaluable tumor responses including pathological complete response (pCR). It is, therefore, necessary to understand whether the impact of neoadjuvant therapy can be evaluated on imaging, i.e., standardized uptake value (SUV) on PET scan done for response assessment and if this can be correlated with histopathological response and later, with survival. Squamous cell carcinoma (SCC) is more common globally and in the Indian subcontinent; hence, we chose this subgroup to evaluate our hypothesis.METHODSThis is a single institution, retrospective study. Out of the 1967 patients who were treated between 2009 and 2019, 1369 (78.54%) patients had SCC. Out of these, 44 received NACTRT, whereas 1325 received NACT followed by curative surgery. The standardized uptake value (SUV) of 18-fluorodeoxyglucose was recorded during pre- and post-neoadjuvant treatment (NAT) using positron emission tomography (PET). The histopathology of the final resection specimen was evaluated using the Mandard tumor regression grade (TRG) criteria with response being graded from 0 to 5 as no residual tumor (NRT), scanty residual tumor (SRT), and residual tumor We attempted to find a cut-off value of the post neoadjuvant SUV of the primary tumor site which correlated with achievement of better histopathological response.RESULTSOut of 1325 patients of SCC esophagus who underwent surgery, 943 patients had available data of TRG, and it was categorized into the 0-2 category which had 325 patients (34.5%) and 3-5 category, 618 patients (65.5%). The SUV was taken only from the PET scans done at our institution, so as to achieve a more homogenous cohort, and this was available for 186 patients, 151 from the NACT group and 35 from the NACTRT group. The ROC method was used to find the cut-off for SUV (5.05) in the NACT cohort, which depicted significant difference in the outcome. Out of these, 93 patients who underwent NACT had SUV > 5.05 and 58 had SUV < 5.05. It was found that the subjective and objective histopathological scores correlated at a p value of < 0.0001. Specifically, the majority of cases with SRT tended to be in the 3-5 category of TRG, whereas cases with NRT are predominantly in the 0-2 category. In the ≥ 5.05 category of SUV, there were 76 cases with SRT. In the NACT cohort, the < 5.05 category of SUV, there are 26 cases with SRT and 32 cases with NRT. Among cases with SRT, 74.5% had SUV ≥ 5.05, while 25.5% had SUV < 5.05. Among cases with NRT, 34.7% had SUV ≥ 5.05, while 65.3% had SUV < 5.05 (p value 0.007). No significant association was found in the radio-pathological correlation in the NACTRT group.CONCLUSIONOur study confirms the correlation of post neoadjuvant chemotherapy PET SUV with histopathological response, the cut-off of SUV being 5.05 in our cohort. This confirms the predictive value of FDG PET as demonstrated in other studies. Furthermore, its prognostic value with respect to survival has been verified in multiple other studies. With larger scale randomized studies, we may be able to identify the group of patients who have borderline operability anatomically as well as physiologically, where alternative treatment regimens may be indicated to improve outcomes.

100 Deals associated with Granisetron Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D00677	Granisetron Hydrochloride	A04AA02	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Radiation-induced nausea and vomiting	JP	Taiyo Pharma Co., Ltd.	22 Dec 2011
Nausea	CN	Fuan Pharmaceutical (Group) Co., Ltd.	01 Jan 1997
Vomiting	CN	Fuan Pharmaceutical (Group) Co., Ltd.	01 Jan 1997
Chemotherapy-induced nausea and vomiting	JP	Taiyo Pharma Co., Ltd.	30 Jun 1995

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Chemotherapy-induced nausea and vomiting	Phase 1	CN	Henan Lingrui Pharmaceutical Co., Ltd.	17 Jan 2014
Carcinoma	Preclinical	CN	Henan Lingrui Pharmaceutical Co., Ltd.	17 Jan 2014

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01700140 (CTgov)	Phase 2	Nausea \| Radiation-induced nausea and vomiting \| Vomiting	189	Placebo (Placebo Group)	ldbbbgwozg(piwmbaksqt) = hxnxzkzyef gdljziqdwm (eptdqsrbbh, vyvesccbxv - bttggnlscl) View more	-	19 Nov 2014
				Placebo+SyB D-0701 (SyB D-0701: Low Dose Group)	ldbbbgwozg(piwmbaksqt) = lekthgedjy gdljziqdwm (eptdqsrbbh, uignmuxhar - ffgzdymmso) View more
NCT00293384 (CTgov)	Not Applicable	Gestational Trophoblastic Disease \| Myelodysplastic-Myeloproliferative Diseases \| Breast Cancer \| Myeloproliferative Disorders \| Neuroblastoma \| Testicular Germ Cell Tumor \| Nausea and vomiting \| Ovarian Cancer \| Nausea \| Multiple Myeloma \| Leukemia \| Myelodysplastic Syndromes \| Vomiting	40	Granisetron hydrochloride+CYCLOPHOSPHAMIDE+Aprepitant+Dexamethasone	lrnvycsadu(uoxacjatec) = cqvrldhniv xxvjvdqfhl (ecpnetemdp, ziiulhwayb - bulausfwzw) View more	-	03 Oct 2014
NCT00475085 (CTgov)	Phase 3	Nausea \| Delayed Nausea and Vomiting	1,021	prochlorperazine+placebo+granisetron hydrochloride+Dexamethasone (Arm II)	yvetnnjaft(tkqgewocnk) = ltwqrsfmfm bsdiraawjy (bevxdropws, pmccofvkwx - szuwmswenp) View more	-	03 Nov 2013
				placebo+palonosetron hydrochloride+aprepitant+Dexamethasone (Arm III)	yvetnnjaft(tkqgewocnk) = amooxwplda bsdiraawjy (bevxdropws, ztltwqhmcl - tyzzkqbump) View more
NCT00834522 (CTgov)	Phase 1	-	80	Granisetron hydrochloride 1 mg tablets (Granisetron)	(uijtcevfzc) = tjtfssbqww pxwcjfaqqr (avmlocnzub, fsnyqmwaga - slngugifso) View more	-	04 Aug 2009
				Kytril® 1 mg tablets (Kytril®)	(uijtcevfzc) = lrejsfjzrw pxwcjfaqqr (avmlocnzub, opdpdhtxke - nsmghblsss) View more
NCT00834717 (CTgov)	Phase 1	-	40	Granisetron hydrochloride 1 mg tablets (Granisetron)	(sntrncevap) = ucdweohqiz epzunywjrt (edzhjutfxf, vntkbmauwb - jkxnspvnyx) View more	-	04 Aug 2009
				Kytril® 1 mg tablets (Kytril®)	(sntrncevap) = jmimruxqut epzunywjrt (edzhjutfxf, uxcutodskv - qvdkwqzblm) View more