Healthy volunteers
Conditions
Interventions
Trade Name: Deflamat-Gel 2%
Product Name: Deflamat-Gel 2%
Pharmaceutical Form: Gel
INN or Proposed INN: Diclofenac
CAS Number: 15307-86-5
Concentration unit: % percent
Concentration number: 2-
Pharmac
Sponsors
pharmed holding GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers of male and female sex. Age 19 – 45 years. BMI between 19 and 26 kg/cm2 . Volunteer is healthy according to the results of the medical examination and without relevant medical problems. Volunteer is able to understand and sign the Informed Consent. Volunteer is able to participate in the entire study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known sensitivity against Diclofenac or Lidocaine. Participation in a study within the last 3 months. Donation of blood within the last 8 weeks. Use of any OTC medication within the last 3 days. Use of Diclofenac or Lidocaine containing medications within the last 2 weeks. Abuse of alcohol, drugs or drugs of abuse. Blodd pressure (seated) lower then 90/65 or higher then 135/90 mmHg Smoker, more than 20 cigarettes a day. Chronic diseases in the anamnesis or acute sickness. Any relevant skin disturbances or diseases. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to investigate, whether Diclofenac and Lidocaine in combination have a stronger effect on the reduction of pain perception than Diclofenac or Lidocaine in identical concentrations alone.;Secondary Objective: ;Primary end point(s): not applicable | — |
Countries
Austria
Outcome results
None listed