Indapamide Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

A phase 4 clinical trial sponsored by Ain Shams University evaluates the pharmacogenomics of indapamide within an Egyptian population cohort, specifically examining how genetic polymorphisms in uridine diphosphate glucuronosyltransferase influence the drug's pharmacokinetics. Currently maintaining an unknown recruitment status, this interventional study reflects targeted efforts to elucidate the genetic determinants governing indapamide metabolism and disposition in specific demographics.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05294484	Unknown status	Pharmacogenomics	Ain Shams University	2022-03-15	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Indapamide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Indapamide binds to and inhibits the sodium-chloride cotransporter in the renal distal convoluted tubules, thereby blocking transepithelial sodium and chloride reabsorption and reducing intracellular solute accumulation. This inhibition enhances renal natriuresis and diuresis to decrease plasma volume, providing the therapeutic basis for managing hypertension and edema while underpinning pharmacogenomic investigations into pharmacokinetic variability.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).