Acebutolol HCl Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

A completed Phase 4 clinical trial sponsored by academic and medical institutions, such as Seoul National University Hospital, Oita University, and Kyushu University, evaluated the pharmacokinetics and disposition of Acebutolol HCl in healthy volunteers. The trial examined how specific transporter gene polymorphisms and dietary factors influence drug absorption. Consequently, available trial data focuses on drug-interaction mechanisms and disposition in healthy subjects rather than broad therapeutic efficacy across disease cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01514019	Completed	Healthy	In-Jin Jang MD PhD\|Oita University\|Seoul National University Hospital\|Kyushu University	2012-01	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Acebutolol HCl acts as a competitive beta-adrenergic receptor antagonist that binds myocardial beta-1 receptors to inhibit catecholamine-induced adenylate cyclase activation and intracellular cyclic AMP production. This biochemical inhibition reduces sinoatrial rate and myocardial contractility, establishing the physiological mechanism evaluated in healthy human trials and utilized clinically to manage hypertension, angina pectoris, and cardiac arrhythmias.

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>).