CTRI/2021/01/030486
Completed
Phase 3
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 sites120 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: E898- Other postprocedural endocrine andmetabolic complications and disorders
- Sponsor
- The ACME LaboratoriesLtd
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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