Tinidazole Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple clinical trials evaluate the therapeutic application of tinidazole for infectious gynecological conditions, specifically targeting refractory trichomonas vaginitis and recurrent bacterial vaginosis. Sponsored by entities including Shangrong Fan at Peking University Shenzhen Hospital and Kaiser Permanente, these Phase 2 and unassigned-phase studies encompass recruitment statuses ranging from not yet recruiting to withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05383521	Not yet recruiting	Trichomonas Vaginitis	Shangrong Fan\|Peking University Shenzhen Hospital	2023-12-01	Not Applicable
NCT00324142	Withdrawn	Recurrent Bacterial Vaginosis	Kaiser Permanente		Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tinidazole undergoes intracellular reduction by electron transport proteins within susceptible anaerobic microorganisms to generate reactive nitro radical intermediates that induce double-stranded DNA breakage and inhibit nucleic acid synthesis. This profound disruption of genomic integrity causes microbial cell death, providing the mechanistic basis for eliminating pathogens implicated in trichomonas vaginitis and recurrent bacterial vaginosis.

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>).