Intravenous Labetalol Versus Oral Nifedipine in The Control of Blood pressure in Severe Hypertensive disorders of Pregnancy: A Randomised Controlled Trial

Start Date01 Jul 2025

Sponsor / Collaborator-

CTR20250957

/ Active, not recruitingNot Applicable

盐酸拉贝洛尔片（200mg）在中国健康受试者中餐后给药条件下随机、开放、单剂量、两制剂、两序列、四周期、完全重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period, fully repeated crossover bioequivalence study of labetalol hydrochloride tablets (200 mg) in Chinese healthy subjects after meal administration

主要研究目的：按有关生物等效性试验的规定，选择Aspen Pharma Schweiz GmbH, Baar.为持证商的盐酸拉贝洛尔片（商品名：Trandate，规格：200mg）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拉贝洛尔片（规格：200mg）进行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，评价两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂盐酸拉贝洛尔片（规格：200mg）和参比制剂盐酸拉贝洛尔片（商品名：Trandate，规格：200mg）的安全性。

[Translation]

Main study purpose: According to the relevant provisions of bioequivalence test, labetalol hydrochloride tablets (trade name: Trandate, specification: 200 mg) of Aspen Pharma Schweiz GmbH, Baar. as the licensee were selected as the reference preparation, and the test preparation labetalol hydrochloride tablets (specification: 200 mg) produced and provided by Shijiazhuang Siyao Co., Ltd. were subjected to human bioequivalence test after meal administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under the condition of postprandial administration. Secondary study purpose: To observe the safety of oral administration of the test preparation labetalol hydrochloride tablets (specification: 200 mg) and the reference preparation labetalol hydrochloride tablets (trade name: Trandate, specification: 200 mg) in healthy subjects.

Start Date07 Apr 2025

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20250958

/ Active, not recruitingNot Applicable

盐酸拉贝洛尔片（200mg）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两制剂、两序列、四周期、完全重复交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Aspen Pharma Schweiz GmbH, Baar.为持证商的盐酸拉贝洛尔片（商品名：Trandate，规格：200mg）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拉贝洛尔片（规格：200mg）进行空腹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给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂盐酸拉贝洛尔片（规格：200mg）和参比制剂盐酸拉贝洛尔片（商品名：Trandate，规格：200mg）的安全性。

[Translation]

Main study purpose: According to the relevant provisions of bioequivalence test, labetalol hydrochloride tablets (trade name: Trandate, specification: 200 mg) of Aspen Pharma Schweiz GmbH, Baar. as the licensee were selected as the reference preparation, and the test preparation labetalol hydrochloride tablets (specification: 200 mg) produced and provided by Shijiazhuang Siyao Co., Ltd. were subjected to fasting human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions. Secondary study purpose: To observe the safety of oral administration of the test preparation labetalol hydrochloride tablets (specification: 200 mg) and the reference preparation labetalol hydrochloride tablets (trade name: Trandate, specification: 200 mg) in healthy subjects.

Start Date07 Apr 2025

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

100 Clinical Results associated with Labetalol Hydrochloride

100 Translational Medicine associated with Labetalol Hydrochloride

100 Patents (Medical) associated with Labetalol Hydrochloride

4,198

Literatures (Medical) associated with Labetalol Hydrochloride

24 May 2025·Journal of Biomolecular Structure and Dynamics

Integration analysis of PLAUR as a sunitinib resistance and macrophage related biomarker in ccRCC, an in silicon and experimental study

Article

Author: Tian, Yijun ; Li, Lin ; Yang, Qiwei ; Jiang, Aimin ; Chu, Jian ; Gan, Sishun ; Cao, Jianwei ; Ye, Fangdie

Sunitinib remains the preferred systemic treatment option for specific patients with advanced RCC who are ineligible for immune therapy. However, it's essential to recognize that Sunitinib fails to elicit a favourable response in all patients. Moreover, most patients eventually develop resistance to Sunitinib. Therefore, identifying new targets associated with Sunitinib resistance is crucial. Utilizing multiple datasets from public cohorts, we conducted an exhaustive analysis and identified a total of 8 microRNAs and 112 mRNAs displaying significant expression differences between Sunitinib responsive and resistant groups. A particular set of six genes, specifically NIPSNAP1, STK40, SDC4, NEU1, TBC1D9, and PLAUR, were identified as highly significant via WGCNA. To delve deeper into the resistance mechanisms, we performed additional investigations using cell, molecular, and flow cytometry tests. These studies confirmed PLAUR's pivotal role in fostering Sunitinib resistance, both in vitro and in vivo. Our findings suggest that PLAUR could be a promising therapeutic target across various cancer types. In conclusion, this investigation not only uncovers vital genes and microRNAs associated with Sunitinib resistance in RCC but also introduces PLAUR as a prospective therapeutic target for diverse cancers. The outcomes contribute to advancing personalized healthcare and developing superior therapeutic strategies.

01 May 2025·CNS Drugs

Is the Effect of Intensive Antihypertensive Treatment in Acute Intracerebral Hemorrhage Dependent on Hematoma Volume? A Traditional Meta-analysis of the Effect of Antihypertensive Regimens, a Bayesian Network Meta-analysis of the Mortality of Antihypertensive Drugs and Systematic Review

Review

Author: Bao, Yijun ; Li, Cong ; Li, Kunhang ; Shi, Xin ; Li, Zhi ; Li, Lishuai

BACKGROUND AND OBJECTIVES: Intensive or conventional antihypertensive treatment for acute intracerebral hemorrhage is still controversial. This study aimed to compare those antihypertensive regimens and analyze the efficacy of antihypertensive drugs.METHODSRetrieval was conducted through four databases. Meta-analysis and Bayesian network meta-analysis were performed to evaluate the safety of antihypertensive treatments and the efficacy of antihypertensive drugs.RESULTSA total of 9271 patients were included. Intensive strategy showed an advantage in 24-h hematoma enlargement (relative risk, RR = 0.76; 95% confidence intervals, CI = 0.67-0.87; P < 0.0001) and 90-day intracranial rebleeding (RR = 0.71, 95% CI = 0.52-0.96, P = 0.03) compared with conventional strategy. Meanwhile, the 90-day renal insufficiency (RR = 2.31, 95% CI = 1.05-5.05, P = 0.04) and renal failure (RR = 2.42, 95% CI = 1.20-4.86, P = 0.01) were increased. When cerebral hematoma volume was less than 15 ml, intensive strategy had a protective effect on 24-h hematoma enlargement (RR = 0.77, 95% CI = 0.67-0.89, P = 0.0003), but it increased 90-day renal failure (RR = 2.33, 95% CI = 1.07-5.04, P = 0.03). For the volume greater than 15 ml, it enhanced 90-day functional independence (RR = 0.78, 95% CI = 0.65-0.94, P = 0.01) and decreased intracranial rebleeding (RR = 0.68, 95% CI = 0.49-0.94, P = 0.02). Labetalol was the best, with the mortality risk probability of 0.09 and the surface under the cumulative ranking curve of 0.33.CONCLUSIONSThis meta-analysis suggests that for intracerebral hematoma volume greater than 15 ml, intensive antihypertensive treatment can improve functional independence and reduce intracranial bleeding. Labetalol has the best effect among the four antihypertensive regimens studied.

01 Apr 2025·Separation and Purification Technology

Using artificial neural networks to elucidate retention interactions on stationary phases with amine moieties dedicated to supercritical fluid chromatography

Author: Garrigues, Jean-Christophe ; Plachka, Katerina ; Svec, Frantisek ; Plachká, Kateřina ; Gazarkova, Tatana ; Pilařová, Veronika ; Novakova, Lucie ; Švec, František ; Gazárková, Taťána ; Pilarova, Veronika ; Nováková, Lucie

The retention mechanisms of small mols. on a wide range of stationary phases using different mobile phase compositions are one of the most discussed topics in current state-of-the-art supercritical fluid chromatog. (SFC).Although various theories have been published on retention behavior, prediction, and stability over time, an in-depth insight into the mechanisms is still lacking.Our study focused on the description of the retention mechanisms on columns with amine moieties, i.e., 2-ethylpyridine, 2-picolylamine, 1-aminoanthracene, and diethylamine, dedicated to SFC, using three different compositions of organic modifier, i.e., methanol, methanol + 10 mmol/L NH₃, and methanol + 2% H₂O, in CO₂.An extensive set of analytes characterized by more than 200 mol. descriptors was used.The importance of the effect of each mol. descriptor on the retention behavior was determined by artificial neural networks.Thus, the descriptors increasing and/or decreasing retention on individual columns using different mobile phase compositions were defined.The data collected over one year of column use were statistically evaluated to describe the retention behavior of small mols. on the tested stationary phases using three organic modifiers and to describe the changes in retention behavior over time.As the development of the SFC method can be laborious and time-consuming, this publication offers a detailed description of the interactions taking place between the analyte and the SFC stationary phase.Understanding these fundamental processes will enable faster development of SFC methods using quality-by-design principles.

News (Medical) associated with Labetalol Hydrochloride

03 Sep 2024

·www.pharmaceutical-technology.com

ESC 2024: Beta blocker treatment paradigm shifts for myocardial infarction

At the ESC Congress, Dr. Milton Packer highlighted recent research into beta blocker treatment for myocardial infarction. Credit: luchschenF via Shutterstock. A shift in the beta-blocker treatment paradigm has arrived with the changing myocardial infarction treatment landscape, said a researcher at the European Society of Cardiology (ESC) Congress, held from 31 August to 2 September. Over the past 40 years, the research space has operated on an understanding that immediate inhibition by beta-blockers reduces left ventricular rupture, and further myocardial infarction , said Dr. Milton Packer, distinguished scholar in cardiovascular science at Baylor University Medical Center, Dallas. Additionally, the belief was that delayed long-term blockade can lead to left ventricular dysfunction, he said. Beta-blockers are a class of drugs that act by inhibiting the actions of hormones such as adrenaline to slow down the heart. Commonly used beta blockers include Abbott ’s Tenormin (atenolol), MSD’s Cardicor (bisoprolol), and GSK ’s Trandate (labetalol). However, Packer explained that the beta blocker response has changed as percutaneous interventions, reperfusion therapies, antiplatelet drugs and more have entered the treatment landscape for myocardial infarction. At the ongoing ESC Congress talk titled “Should we give beta blockers post-myocardial infarction?” Packer said that questions have been raised surrounding the use of the drugs in patients with myocardial infarction and preserved ejection fraction, referencing the Phase IIII REDUCE-AMI study (NCT03278509). See Also: Novavax wins FDA emergency approval for updated Covid-19 vaccine Combating Pharmaceutical Crime with On-Dose Authentication REDUCE-AMI, which was funded by the Swedish Research Council, tested the use of beta-blockers after myocardial infarction and preserved ejection fraction. The study found that for patients with acute myocardial infarction who underwent early coronary angiography and had preserved left ventricular ejection fraction, long-term beta-blocker treatment did not lower the risk of death from any cause or new myocardial infarctions compared to no beta-blocker use. Despite the conclusion of the REDUCE-AMI study, Packer highlighted the fact that researchers have only investigated and proven the effectiveness of non-selective beta blockers in post-myocardial infarction trials, so further research is required. He added that physicians will have to take into account the degree of beta-blockade in future treatment regimens.

VaccinePhase 3Drug ApprovalClinical Result

17 Jun 2024

·www.drugs.com

2008 to 2021 Saw Increase in Prevalence of Chronic HTN in Pregnancy

MONDAY, June 17, 2024 -- For pregnant individuals, the prevalence of chronic hypertension more than doubled between 2008 and 2021, according to a study published online June 17 in Hypertension . Stephanie A. Leonard, Ph.D., from the Stanford University School of Medicine in California, and colleagues analyzed commercial insurance claims from 2007 to 2021 and assessed the prevalence of chronic hypertension during pregnancy and trends in oral antihypertensive medication use. The researchers found that between 2008 and 2021, the prevalence of chronic hypertension increased steadily from 1.8 to 3.7 percent among 1,900,196 pregnancies. During the study period, antihypertensive medication use among those with chronic hypertension was relatively stable (57 to 60 percent). There was a decrease seen in the proportion of pregnant individuals with chronic hypertension treated with methyldopa or hydrochlorothiazide (from 29 to 2 percent and from 11 to 5 percent, respectively), and there was an increase seen in the proportion treated with labetalol or nifedipine (from 19 to 42 percent and from 9 to 17 percent, respectively). Following the 2017 American College of Cardiology and American Heart Association hypertension guidelines, there was no change observed in the prevalence or treatment of chronic hypertension during pregnancy. "There were large shifts in the medications used to treat chronic hypertension in pregnancy, with labetalol supplanting methyldopa as the most commonly used antihypertensive medication," the authors write. One author disclosed ties to the pharmaceutical industry.

AHAClinical Study

23 May 2024

·www.fiercepharma.com

Pfizer's Hospira recalls 5 injectable drug lots due to report of leak, potential seal issues

Recalled batches of Hospira's buprenorphine hydrochloride (HCI) injection and its labetalol hydrocholoride injection were distributed to hospitals and wholesalers nationwide between September 2023 and April 2024, according to a notice posted on the FDA website. After a report of leaking product, Pfizer’s Hospira unit is pulling five lots of sterile injectable medicines from distribution. The recall affects certain batches of the company’s buprenorphine hydrochloride (HCI) injection and its labetalol hydrocholoride injection, both of which come in Pfizer’s Carpuject syringe device. While the company has not yet received reports of “any relevant” adverse events tied to the recalled batches, it opted to pull the meds due to the potential for incomplete crimp seals. The concern followed one custumer complaint about a leaking product, Pfizer said in a notice posted by the FDA. Hospira’s buprenorphine product is indicated for intravenous or intramuscular administration to treat pain management that requires an opioid analgesic, while the labetalol HCI product controls blood pressure during severe hypertension. The recalled batches were distributed to wholesalers and hospitals across the U.S. between September 2023 and April of this year. The buprenorphine HCI lots expire in September and October of this year, while the three lots of labetalol injections carry expiration dates in 2025. Pfizer is arranging for the return of the affected products and instructed those with remaining inventory to discontinue use, stop distribution and quarantine the injections immediately. Late last year, contamination concerns led to mutiple recalls for the Pfizer subsidiary. First, the company yanked one lot of its injectable cancer med bleomycin after a customer flagged glass particulates in one vial. Then, two strengths of injectable sodium bicarbonate and one lot of atropine sulfate injection were pulled due to the “potential presence of glass particulate matter” spotted during routine product inspections. The spree continued with another market pull of one lot of vancomycin hydrochloride injection vials. That recall was attributed to a report of two visible glass particles in one vial.

Drug ApprovalClinical Result

100 Deals associated with Labetalol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00600	Labetalol Hydrochloride	C07AG01	DB00598

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	China	Jiangsu Desano Pharmaceutical Co. Ltd.	01 Jan 1985
Essential Hypertension	Japan	Sandoz AG	07 Oct 1982

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DOPPS (ISN WCN2024)	Not Applicable	Maintenance	-	Metoprolol	(jyeyqkqqdr): P-Value = 0.83	Positive	01 Apr 2024
				Atenolol
NCT04343235 (CTgov)	Phase 4	Hypertension, Pregnancy-Induced	13	labetalol+Furosemide (Labetalol + Furosemide)	bfvxzytytc(swnhlpitnc) = xgzlqawmge bxvziijyoj (nairbschqk, qtffkeiotv - wdikwnsmnz) View more	-	23 Oct 2023
				labetalol (Labetalol Only)	bfvxzytytc(swnhlpitnc) = gdovlbrfvd bxvziijyoj (nairbschqk, rwfiqjiyir - ysokjbhdtp) View more
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	dsrzjcmwlu(zmejzbfkme) = wgimlbfgiv yuxdlhtgds (zilpnswcba, lrqozkasdu - qzdwtoovwk) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	dsrzjcmwlu(zmejzbfkme) = fwgippfmub yuxdlhtgds (zilpnswcba, gyouroktjh - wubqtglotj) View more
NCT04539379 (ZU-IRB#: 6353-23-3-2020, Pubmed \| J Clin Monit Comput)	Not Applicable	Pre-Eclampsia	-	Magnesium sulfate	wtaflandju(bhqirafkpf) = yeuhsfifpe zibbeyquip (ewqqbkdqvh )	Positive	01 Aug 2023
				Labetalol	wtaflandju(bhqirafkpf) = ibjxlddfpu zibbeyquip (ewqqbkdqvh )
NCT03809065 (Pubmed \| BMC Anesthesiol)	Phase 4	Hypotension	40	Nitroglycerin	aelnvfpqwm(dfambbezbr) = waiqxxgzte kuzajxqaue (mlcmgikcsf )	-	17 Apr 2020
				Labetalol	aelnvfpqwm(dfambbezbr) = qfezmerbzr kuzajxqaue (mlcmgikcsf )
ISN WCN2020	Not Applicable	First line \| Add-on	56	IV Labetalol	mklqoywxlm(fegxtpvjqe) = vxcldvbiwv yhqrpefxrs (tbcsofkdzv ) View more	Positive	01 Mar 2020
				IV Nitroprusside/Nitroglycerine	mklqoywxlm(fegxtpvjqe) = jfegrdsqfi yhqrpefxrs (tbcsofkdzv ) View more
NCT01114971 (CTgov)	Phase 4	Pain, Postoperative	75	Esmolol+Labetalol (Fentanyl)	(lrxcafputw) = hsywrzqsoe efqtbcffdm (dbxryhxbzm, vlktxgybny - cjgtqgdlzk) View more	-	20 Feb 2020
				Esmolol+Fentanyl (Labetalol)	(lrxcafputw) = latvkxurxk efqtbcffdm (dbxryhxbzm, coblnkbzti - zaxaibqhth) View more
ISC2019	Not Applicable	-	205	No antihypertensive	aoahsgqjbm(irnzdbvxdd) = oahdjvluoe umbpxhfscu (zyxshznyeh )	-	01 Feb 2019
				Labetalol	qnwrcokyrd(wqwnlscpct) = sonfcimjsk mgsjacorze (vawhkfcjks ) View more
ISRCTN40973936 (Pubmed \| Hypertension)	Not Applicable	Hypertension, Pregnancy-Induced First line	112	Labetalol	oojefntflp(xlltvfpqxg) = Nifedipine use was associated with a 7.4-mm Hg reduction (-14.4 to -0.4 mm Hg) in central aortic pressure, measured by pulse wave analysis vqlklvdgos (qjgmdlxmwl )	-	01 Nov 2017
				Nifedipine-modified release
NCT02168309 (Pubmed \| Hypertens Pregnancy)	Not Applicable	Hypertension	50	Oral labetalol	rqmekgyzoq(qbfbsqbhti) = groatmrxvi daqahfplqz (dgcxutylfd )	-	02 Jan 2017
				Oral extended release nifedipine	rqmekgyzoq(qbfbsqbhti) = swuoajmhhj daqahfplqz (dgcxutylfd )

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