Felodipine Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Numerous clinical trials, the vast majority of which are completed, evaluate the pharmacokinetics, bioequivalence, and therapeutic efficacy of felodipine across Phase 1 through Phase 4. Sponsored by leading pharmaceutical corporations and institutional research centers, these studies primarily target cardiovascular pathologies such as hypertension and left ventricular hypertrophy, alongside secondary indications including obesity, insulin resistance, microvascular impairment, and lung transplantation-related disorders. Additionally, clinical research has evaluated felodipine-based combination therapies to assess blood pressure control and cardiac remodeling biomarkers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05614037	UNKNOWN	Hypertension	Overseas Pharmaceuticals, Ltd.	2022-10-28	PHASE1
NCT02744872	COMPLETED	Disorder Related to Lung Transplantation	Rigshospitalet, Denmark	2013-09	PHASE4
NCT01520285	COMPLETED	Hypertension	Lee's Pharmaceutical Limited	2011-12	PHASE4
NCT02232269	COMPLETED	Food-Drug Interactions	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	2012-02	PHASE1
NCT01238705	UNKNOWN	Hypertension; Sexual Dysfunction	LanZhou University	2008-04	PHASE4
NCT00841880	COMPLETED	Hypertension	Sanofi	2009-01	PHASE4
NCT00742066	UNKNOWN	Hypertension; Insulin Resistance; Microcirculation	Maastricht University Medical Center	2008-03
NCT00905333	COMPLETED	Healthy	AstraZeneca	2008-10	PHASE1
NCT02327247	COMPLETED	Healthy	Ranbaxy Laboratories Limited	2008-09
NCT02311530	COMPLETED	Healthy	Ranbaxy Laboratories Limited	2008-10
NCT02311530	Completed	Healthy	Ranbaxy Laboratories Limited\|Ranbaxy Inc.	2008-10	Not Applicable
NCT02327247	Completed	Healthy	Ranbaxy Laboratories Limited\|Ranbaxy Inc.	2008-09	Not Applicable
NCT00348686	COMPLETED	Hypertension; Left Ventricular Hypertrophy	AstraZeneca	2006-06	PHASE4
NCT00507845	COMPLETED	Hypertension	Sanofi	2007-06	PHASE4
NCT00392262	COMPLETED	Hypertension	Novartis	2006-08	PHASE3
NCT00392262	Completed	Hypertension	Novartis	2006-08	Phase 3
NCT00367939	COMPLETED	Hypertension	Novartis	2005-12	PHASE3
NCT02336607	COMPLETED	Hypertension	AstraZeneca	2005-12
NCT00348686	Completed	Hypertension\|Left Ventricular Hypertrophy	AstraZeneca	2006-06	Phase 4
NCT00861016	COMPLETED	Hypertension	AstraZeneca	2005-10	PHASE4
NCT01136863	COMPLETED	Hypertension	Chinese Academy of Medical Sciences	1998-04
NCT00679653	COMPLETED	Obesity; Hypertension	Abbott	2002-02	PHASE3
NCT01630902	COMPLETED	Healthy	Torrent Pharmaceuticals Limited		PHASE1
NCT01630655	COMPLETED	Healthy	Torrent Pharmaceuticals Limited		PHASE1

(data from https://clinicaltrials.gov, updated on 2023-02-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Felodipine selectively binds to L-type voltage-gated calcium channels on vascular smooth muscle cell membranes, inhibiting transmembrane calcium influx and preventing intracellular calcium-mediated excitation-contraction coupling. This blockade leads to peripheral arterial vasodilation and reduced vascular resistance, providing the pharmacological rationale for its clinical use in managing hypertension and left ventricular hypertrophy.

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>).