Lisinopril dihydrate Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple Phase I clinical trials evaluate the comparative pharmacokinetic properties and bioequivalence of oral Lisinopril formulations in healthy volunteers. Sponsoring organizations include pharmaceutical entities such as Pharmtechnology LLC, ClinPharmInvest LLC, and Bright Future Pharmaceuticals Factory, alongside academic institutions like the Chinese University of Hong Kong. These studies comprise both completed trials and entries with an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05061901	Completed	Bioequivalence	Pharmtechnology LLC\|ClinPharmInvest LLC	2021-10-06	Phase 1
NCT03599466	Unknown status	Healthy	Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited\|Chinese University of Hong Kong	2019-10	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lisinopril dihydrate functions as a potent competitive inhibitor of angiotensin-converting enzyme, preventing the cleavage of angiotensin I into angiotensin II and suppressing downstream aldosterone secretion. This biochemical blockade attenuates vascular smooth muscle contraction and lowers peripheral resistance, providing the pharmacological rationale for its evaluation in bioequivalence trials in healthy subjects for the management of hypertension and congestive heart failure.

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>).