A Single-dose, Open-label, Randomized, 2-way, Cross-over Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer From Viatris to Neolpharma, for Spironolactone/Hydrochlorothiazide Film Coated Tablets in Healthy Adult Participants Under Fasted Conditions.

The purpose of the study is to understand how the body processes Spironolactone and Hydrochlorothiazide after taking Spironolactone and Hydrochlorothiazide film coated tablets manufactured at two sites: Viatris and Neolpharma by mouth.
The study is seeking for:
* Both male and female participants.
* participants who must be 18 to 75 years of age.
* Body Mass Index of participants should be 16 to 32 kilogram per meter squared and body weight should be more than 50 kilograms (110 pounds).
About 40 participants will enter the study (20 in each group). Study consists of two periods. On Day 1 of each period, participants will receive a single amount of Spironolactone and Hydrochlorothiazide tablets. The total duration of study will be 71 days. Follow up may occur via telephone after 35 days after taking the final tablet of the study medicine.

Start Date26 Dec 2023

Sponsor / Collaborator

Pfizer Inc.

NCT04465123

/ Unknown statusPhase 3IIT

Furosemide With Early Sequential Nephron Blockade Versus Furosemide Alone in Acute Heart Failure Patients With Furosemide-guided Diuretic Resistance: A Double-blinded, Randomized, Placebo-controlled Study

This study aims to demonstrate the efficacy of sequential nephron blockade by adding hydrochlorothiazide or spironolactone on intravenous furosemide compared to intravenous furosemide alone in the treatments of volume overload in patients with acute heart failure who have diuretic resistance from furosemide stress test.

Start Date13 Aug 2020

Sponsor / Collaborator

Chiang Mai University

100 Clinical Results associated with Hydrochlorothiazide/Spironolactone

100 Translational Medicine associated with Hydrochlorothiazide/Spironolactone

100 Patents (Medical) associated with Hydrochlorothiazide/Spironolactone

Literatures (Medical) associated with Hydrochlorothiazide/Spironolactone

01 Apr 2013·GastroenterologyQ1 · MEDICINE

An Unusual Case of Chronic Diarrhea

Q1 · MEDICINE

Article

Author: Cheryl J. Bunker ; Gauree Gupta Konijeti ; Vikram Deshpande

An 80-year-old man with a history of Henoch-Schonlein Purpura at the age of 59 requiring partial jejunal resection, coronary artery disease, CKD, gout, GERD, and prior cholecystectomy was admitted for 2 weeks of guaiac positive watery brown diarrhea and dehydration. Medications included aspirin 81mg daily, clopidogrel, aldactazide, furosemide, hydralazine, isosorbide mononitrate, metoprolol, simvastatin, lansoprazole, allopurinol, trazodone, and tamsulosin. He had switched from citalopram to bupropion two weeks prior. He was afebrile and hemodynamically stable. His abdomen was distended and tympanitic, with normal bowel sounds and tenderness to palpation over the epigastrium and periumbilical area, but no peritoneal signs. Laboratory evaluation revealed creatinine 1.96 mg/dL, WBC 8.8×109/L with 81% neutrophils, c-reactive protein (CRP) 27.2 mg/L. Urinalysis, stool culture, C. diff toxin, ova & parasites, and serum anti-TTG IgA/IgG were negative. Abdominal CT scan and upper endoscopy with duodenal biopsies were unremarkable. Colonoscopy revealed a >15cm linear ulcer in the descending colon and mild patchy erythema in the proximal colon (Figure A). Right and left colonic biopsies showed mildly active colitis, with sloughing of the surface epithelium and increased intraepithelial lymphocytes (Figure B). He symptomatically improved during his 6-day hospitalization. Following discharge, he was started on balsalazide 750mg po tid and nightly mesalamine enemas for presumed ulcerative colitis. Figure A Figure B He was readmitted 1 month later with voluminous diarrhea and dehydration. Physical exam, stool microbiology, and repeat abdominal CT scan were identical to his first admission. Laboratory evaluation revealed WBC 11.2×109/L with 86% neutrophils, and CRP 125.5 mg/L. Flexible sigmoidoscopy demonstrated two long linear ulcers in the descending colon with patchy moderate inflammation, submucosal hemorrhages, and shallow ulcerations in the rectum, sigmoid, and descending colon (Figure C). Biopsies revealed collagenous colitis with a markedly thickened subepithelial collagen table (Figures D&E). Re-review of his initial colonoscopic biopsies suggested lymphocytic colitis. He symptomatically improved on methylprednisolone and was transitioned to a prednisone taper. Figure C Figure D Figure E Further history uncovered that 3 months prior to his initial presentation he switched to one of his present medications from a related medication for insurance reasons, so we discontinued this medication and rapidly tapered the prednisone over 3 weeks. His symptoms resolved completely. Colonoscopy performed 6-7 weeks after steroids were discontinued was normal (Figure F), including normal biopsies from the right and left colon (Figure G). Figure F Figure G Question: What is the most likely cause of his drug-induced microscopic colitis? Answer to the Clinical Challenges and Images in GI Question: Lansoprazole Microscopic colitis (MC) is characterized by chronic watery diarrhea. Typically colonoscopy reveals normal-appearing colonic mucosa. Biopsy findings may indicate either lymphocytic colitis (LC), with increased intraepithelial lymphocytes (>20 lymphocytes per 100 surface epithelial cells), or collagenous colitis (CC), characterized by a thick subepithelial collagen band (>10 μm). The cause of microscopic colitis is unknown. Medications found to have a high likelihood of causing microscopic colitis include acarbose, aspirin, lansoprazole, nonsteroidal anti-inflammatory drugs (NSAIDs), ranitidine, sertraline, ticlopidine, cyclo3fort, and cirkan [1]. The first cases of lansoprazole-induced MC were published in 2001 following a national formulary change from omeprazole to lansoprazole in the VA hospital system. A recently published case series and systematic review of cases of lansoprazole-induced MC found a median time of symptom onset after lansoprazole initiation of 28 days in LC and 60 days in CC [2]. Macroscopic findings such as linear ulcers and submucosal hemorrhages were more common in lansoprazole-induced CC (72.2%) than in lansoprazole-induced LC (6.6%). Other reports of macroscopic findings in microscopic colitis describe associations with NSAIDs, aspirin, lansoprazole, recent antibiotics, or infection [3]. One retrospective case-control study found an adjusted odds ratio of 4.5 (95% CI 2-9.5) for the association between microscopic colitis and PPI use in the preceding 180 days of MC diagnosis [2]. The prevalence of use of individual PPIs in this cohort was omeprazole (40%), esomeprazole (22.8%), pantoprazole (28.6%), rabeprazole (5.7%), and lansoprazole (2.8%). Management of drug-induced colitis includes removal of the offending agent. In the case of lansoprazole-induced MC, the median time for symptom resolution following drug removal was 7 days for LC, and 14 days for CC [2]. If symptoms do not resolve, treatment can include antidiarrheals, cholestyramine, budesonide, or systemic corticosteroids, depending on the severity of disease. We suspect our patient had lansoprazole-induced microscopic colitis. It is conceivable that his symptom resolution was due to the corticosteroid course rather than discontinuation of the lansoprazole. However, in > 11 months he has not had symptom relapse, his time course is consistent with other published cases of lansoprazole-induced MC, and other potential etiologies of diarrhea were ruled out. Furthermore, he has remained on aspirin, which is also known to be associated with MC, without relapse.

01 Feb 1986·PediatricsQ2 · MEDICINE

Is Chloride Depletion an Important Contributing Cause of Death in Infants With Bronchopulmonary Dysplasia?

Q2 · MEDICINE

Article

Author: Siegel, Marilyn J. ; Moore, Valerie ; Dawson, Jeffrey ; Perlman, Jeffrey M.

A retrospective analysis of infants with bronchopulmonary dysplasia requiring prolonged hospitalization (>100 days) was carried out to determine those factors associated with fatal outcome. Twenty-three infants made up the study population. Eleven infants died and 12 survived (survivors). No differences were noted between the groups regarding ventilator requirement, radiographic changes, and medication use (digoxin, aldactazide), except for furosemide which was used twice as frequently in the group of infants who died v the group of infants who survived (P < .001). Differences noted between the groups included moderate hypochloremia (chloride < 80 mEq/L) in all 11 infants who died v six of 12 survivors, severe hypochloremia (chloride < 70 mEq/L) in the nine of 11 infants who died v two of 12 survivors, metabolic alkalosis (pH > 7.45) in nine of 11 infants who died v three of 12 survivors, hypertension (systolic BP > 113 mm Hg) in eight of 11 infants who died v one of 12 survivors, decrease in head growth in ten of the 11 infants who died v one of the 12 survivors; these differences were all significant (P < .001). The metabolic alkalosis and head growth changes appear to be related to the hypochloremia. The data suggest that chloride deficiency may be an important contributing factor in the genesis of poor outcome in infants with bronchopulmonary dysplasia and that close attention to chloride supplementation might influence outcome.

01 Jul 1985·American Journal of RoentgenologyQ2 · MEDICINE

Recognition and management of renovascular hypertension

Q2 · MEDICINE

Article

Author: Kerlan, RK ; Pogany, AC ; Ring, EJ ; Burke, DR

Dr. Burke. -A 48-year-old woman had intense throbbing headaches for 2 weeks. She smoked (40-pack-year) and was moderately obese, but she was not aware of diabetes, gbmerubonephritis, or pyebonephritis and had no symptoms referable to an arteritis or systemic atherosclerosis. There was no family history of hypertension, diabetes, or arteriosclerotic cardiovascular disease. Physical examination revealed a blood pressure of 220/120 mm Hg. Fundoscopic examination revealed grade I arterial narrowing without hemorrhage, exudate, or arteriovenous nicking. Cardiac examination was normal. Abdominal examination was remarkable for a bruit to the left of the umbilicus and in the left costovertebral angle. Extremity pulses were full. Laboratory tests, including electrolytes, blood urea nitrogen, and creatinine, were normal. Her physician initiated Diazide therapy, but symptomatic hypokalemia developed within 3 weeks, requiring a change in therapy to Aldactazide, 1 mg twice a day, and Inderal, 80 mg three times a day. Over 2 months, her Inderal dose was increased to 1 20 mg four times a day, but this regimen failed to control her hypertension. On referral to a nephrobogist, her blood pressure was 1 90/1 1 0 mm Hg, and diagnostic evaluation was initiated.

100 Deals associated with Hydrochlorothiazide/Spironolactone

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C03EA01	-

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Indication	Country/Location	Organization	Date
Ascites	United States	Pfizer Inc.	27 Jan 1961
Edema	United States	Pfizer Inc.	27 Jan 1961
Essential Hypertension	United States	Pfizer Inc.	27 Jan 1961
Heart Failure	United States	Pfizer Inc.	27 Jan 1961
Liver Cirrhosis	United States	Pfizer Inc.	27 Jan 1961
Nephrotic Syndrome	United States	Pfizer Inc.	27 Jan 1961

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06205407 (CTgov)	Phase 1	-	42	Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Viatris (Treatment A)	wwlqujhqgd(ojoitdkmoz) = bpetjkvvcp hszeygiweh (tairlkovbm, tlzhsqdjni - ucmwuxxjkz) View more	-	21 Mar 2025
				Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Neolpharma. (Treatment B)	emrdfjxfwa(bvudozjkza) = evhubjumkg bdsrtffkht (jdqhkhobhw, vnyvurguvx - pdtkcwtutb) View more

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