Rimantadine Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

A clinical trial sponsored by industry partner Hoffmann-La Roche investigated the pharmacokinetic interactions between Rimantadine and oseltamivir in healthy volunteers. This completed Phase 1 study utilized an open-label, randomized crossover design to assess drug safety, tolerability, and multi-dose interaction profiles. Overall, the available trial dataset provides essential early-stage clinical data to inform potential therapeutic applications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01172847	Completed	Healthy Volunteer	Hoffmann-La Roche	2009-08	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rimantadine selectively inhibits viral M2 proton channel activity, which blocks endosomal proton influx required for virion uncoating and prevents the release of infectious viral nucleic acids into host cells. By suppressing viral replication downstream of channel blockade and demonstrating anti-parasitic activity against Trypanosoma brucei, this agent achieves clinical relevance for evaluating antiviral safety and combination drug interactions in human cohorts.

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>).