Sodium Bicarbonate Clinical Trials

Size	Price	Qty
100mg	USD 90
1g	USD 449

Clinical Trials

Sodium bicarbonate is currently under evaluation in several clinical trials investigating diverse metabolic and organ-system disorders, such as stage 5 chronic kidney disease, hepatic ischemia, biliary atresia, hyperkalemia, and metabolic acidosis. Spanning Phase 3 and non-applicable phase designs, these studies are sponsored by academic medical centers and industry entities, including Osaka University, The First Affiliated Hospital with Nanjing Medical University, AstraZeneca, and Tongji Hospital. Current recruitment statuses across these records include active not recruiting, recruiting, terminated, and unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05350098	Active not recruiting	Chronic Kidney Disease Stage 5	Osaka University	2023-01-01	Not Applicable
NCT05830136	Recruiting	Hepatic Ischemia	The First Affiliated Hospital with Nanjing Medical University	2022-02-01	Not Applicable
NCT04727528	Terminated	Hyperkalaemia\|Metabolic Acidosis\|Chronic Kidney Disease	AstraZeneca	2021-03-22	Phase 3
NCT04506021	Unknown status	Biliary Atresia	Tongji Hospital	2020-08	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium bicarbonate functions as a systemic buffering agent by dissociating into sodium and bicarbonate ions, allowing bicarbonate to combine with excess free hydrogen ions to yield carbonic acid, which subsequently decomposes into carbon dioxide and water. This rapid proton neutralization restores optimal extracellular pH and dampens acidotic biochemical cascades, providing therapeutic benefit in managing metabolic acidosis, hyperkalemia, and ischemia-related tissue injury in chronic kidney disease and surgical contexts.

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>).