Guaifenesin Clinical Trials

Size	Price	Qty
10mg	USD 97

Clinical Trials

Multiple completed Phase 1 clinical trials sponsored by Reckitt Benckiser LLC evaluated guaifenesin-containing pharmaceutical formulations to investigate pharmacokinetic parameters and comparative drug exposure in healthy adult subjects. These industry studies assessed the bioequivalence, relative bioavailability, and single-dose pharmacokinetic profiles of extended-release bi-layer and high-strength formulations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03642262	Completed	Healthy Subjects	Reckitt Benckiser Inc.\|Reckitt Benckiser LLC	2013-06-02	Phase 1
NCT03649750	Completed	Healthy Subjects	Reckitt Benckiser LLC	2013-05-29	Phase 1
NCT03633487	Completed	Healthy Subjects	Reckitt Benckiser LLC	2011-10-11	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Guaifenesin increases the volume and decreases the viscosity of respiratory tract secretions by stimulating bronchial fluid output and altering mucosal glycoprotein interactions. This reduction in mucus viscosity promotes effective mucociliary clearance and enhances cough reflex efficiency, providing the functional mechanism evaluated in pharmacokinetic and bioequivalence studies in healthy subjects.

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>).