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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Clinical trial
• Data collection methods:
  Primary data collection

Clinical trials

• Clinical trial regulatory scope:
  Pre-authorisation clinical trial
• Clinical trial phase:
  Human pharmacology (Phase I)
• Clinical trial randomisation:
  Non-randomised clinical trial
• Clinical trial types:
  Single-arm trial

Study drug and medical condition

• Name of medicine, other:
  Lidocaine dental gel 15% w/v

Population studied

• Short description of the study population:
  12 healthy volunteers
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)