Plasma concentration of lidocaine and its metabolites after topical application of Lidocainedental gel 15% w/v to the oral mucosa

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000582
• EU PAS number:
  EUPAS1000000582
• Study ID:
  1000000582
• Official title and acronym:
  Plasma concentration of lidocaine and its metabolites after topical application of Lidocaine dental gel 15% w/v to the oral mucosa
• DARWIN EU® study:
  No
• Study countries:
  Greece
• Study description:
  Phase I pharmacokinetic study in 12 healthy volunteers. ; Primary Objective: To determine the plasma levels of lidocaine and its two key metabolites, MEGX and GX,; after topical application of Lidocaine 15% w/v Dental Gel to the oral mucosa.; Secondary Objectives: To evaluate the single-dose pharmacokinetics (PK) of lidocaine and its two key; metabolites, MEGX and GX, after topical application of Lidocaine 15% w/v Dental; Gel to the oral mucosa.
• Study status:
  Finalised

Research institutions and networks

Institutions

CLINICAL RESEARCH UNIT, SCHOOL OF MEDICINE, PAPAGEORGIOU GENERAL HOSPITAL, ARISTOTLE UNIVERSITY OF THESSALONIKI (CRU-AUSoM)

Greece

Study timelines

Date when funding contract was signed

Actual: 31/05/2023

Study start date

Planned: 12/09/2023

Actual: 12/09/2023

Date of final study report

Actual: 21/02/2024

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

EU Trial No. 2022-003798-43