â??A Prospective, Interventional, Open label, Randomized,Parallel Group, Multi-centric, Comparative clinical Study to Evaluate the Efficacy and Safety of test drug, Potassium Chloride (K-Lyte) 600 mg Immediate Release Tablet in comparison to reference drug, Potassium Chloride (Klor-Con) 600 mg Extended Release Tablet in the Treatment of the patients with Hypokalemia.â??

The ACME LaboratoriesLtd0 个研究点目标入组 120 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Ages 18 to 65 years (both gender inclusive)
•2. Patient on the investigating unit found mild to moderate serum potassium level.
•(Mild hypokalemia is a serum level of 3.0 to 3.4 mEq/L, Moderate hypokalemia is a serum level of 2.5-2.9 mEq/L, and severe hypokalemia is a level of less than 2.5 mEq/L.)
•Ability to take oral tablets.
•Normal renal function test.
•Diagnostic Criteria:
•ï??Diagnosed by physician and concluded the need of electrolyte (potassium) supplementation.
•ï??Increased potassium loss
•-Drugs induced hypokalemia: diuretics (thiazides, loop diuretics), laxatives, glucocorticoids, fludrocortisone, penicillins, amphotericin, aminoglycosides etc.
•-GI losses: diarrhoea, vomiting, ileostomy, intestinal fistula
•-Renal causes:dialysis
•-Endocrine disorders: hyperaldosteronism (Connâ??s syndrome), Cushingâ??s syndrome
•Trans-cellular shift
•-Insulin/glucose therapy
•-Salbutamol and other beta-agonists
•-Theophylline
•-Metabolic alkalosis
•Decreased potassium intake
•Magnesium depletion (associated with increased renal potassium loss)
•3. Ethical / legal considerations:
•All the patients are willing to obtain written informed consent, according to national regulations.

•1.Patients with a serum potassium < 2.5 mEq/L and > 3.5 mEq/L.
•2.Patients with serum renal dysfunction with urine output <500ml/day or serum creatinine >2 mg/dL.
•3.Hypomagnesaemia (<= 0.7mmol/L), however patients may be enrolled after the hypomagnesaemia is corrected.
•4.Evidence of Intrinsic source of potassium release includes acute rhabdomyolysis, Hemolytic anemia, and tumor lysis.
•5.Magnesium level < 1.5 mg/dL.
•6.Use of any investigational drug currently or within 30 days prior to study entry.
•7.Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
•8.Patients on any prescription medication that might interfere with study outcomes as decided by investigator.

发起方

The ACME LaboratoriesLtd