Tegobuvir Clinical Trials

Size	Price	Qty
5mg	USD 339

Clinical Trials

Multiple clinical trials sponsored by Samsung Medical Center have evaluated interventions for dyspepsia, with all studies designated as Phase Not Applicable. This research includes an investigation into gastric emptying efficacy in functional dyspepsia patients, currently of unknown recruitment status, and a completed trial assessing gastric accommodation in healthy adults via magnetic resonance imaging. Together, these studies focus on evaluating gastrointestinal motility and accommodation outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02151708	Unknown status	Dyspepsia	Samsung Medical Center	2014-06	Not Applicable
NCT02091635	Completed	Dyspepsia	Samsung Medical Center	2013-08	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tegobuvir covalently binds to the non-nucleoside allosteric site of the hepatitis C virus NS5B RNA-dependent RNA polymerase, directly blocking viral RNA replication and viral protein synthesis. This potent disruption of viral transcription leads to reduced intracellular viral accumulation and cell-to-cell spread, thereby demonstrating therapeutic efficacy in inhibiting hepatitis C virus infection and supporting clinical evaluations associated with dyspepsia and related gastrointestinal conditions.

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>).