Dexlansoprazole Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Multiple clinical trials have evaluated the proton pump inhibitor dexlansoprazole across Phase 1 and Phase 4 research. Takeda sponsored Phase 1 pharmacokinetic and safety assessments, which included a completed study in healthy volunteers and a withdrawn trial in pediatric gastroesophageal reflux disease. Additionally, a completed Phase 4 trial, sponsored by the American University of Beirut Medical Center in partnership with Takeda, investigated dexlansoprazole for heartburn relief in gastroesophageal reflux disease during Ramadan fasting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02442752	Withdrawn	Pediatric Gastroesophageal Reflux Disease	Takeda	2025-06-15	Phase 1
NCT03316976	Completed	Healthy Volunteers	Takeda	2017-11-22	Phase 1
NCT03079050	Completed	GERD\|Proton Pump Inhibitor	American University of Beirut Medical Center\|Takeda	2017-02-27	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dexlansoprazole selectively binds to and inhibits the H(+),K(+)-ATPase proton pump within gastric parietal cells, thereby blocking the final step of hydrogen ion secretion into the stomach lumen. This sustained inhibition reduces gastric acid output and elevates intragastric pH, establishing the therapeutic mechanism for treating gastroesophageal reflux disease and associated heartburn symptoms investigated in clinical studies.

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>).