Clinical trial NCT02201238: Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
Official title: A Pharmacokinetics Study Comparing Systemic Exposure of Topical Diclofenac/Menthol Gels Versus Voltaren Gel and Oral Diclofenac Sodium in Healthy Volunteers at Steady State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-07-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This research study is being conducted to characterize the pharmacokinetic properties of a new topical medication (MFC51123) that contains two active ingredients (diclofenac and menthol) in two formulation packages. One formulation package is in the form of a gel in aluminum tube and the other one in the form of a gel in roll-on applicator bottle. Additionally, as a comparison, the pharmacokinetic properties of a marketed diclofenac gel and an oral diclofenac treatment will also be characterized. This topical diclofenac/menthol gel has being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains. The rationale for conducting the study is to prove that repeated topical treatment of the new diclofenac + menthol formulation in either of the two packages does not result in unsafe systemic exposure.


Eligibility criteria: Inclusion Criteria:

* Participants aged 18 to 50 years
* Body mass index between 19-28 (kg/m2)

Exclusion Criteria:

* Pregnant or lactating females
* Participants having intolerance or hypersensitivity to study material
* Participants having positive results for HIV, Hepatitis B or Hepatitis C
* Participants having skin lesion at site of application
* Participants having history of alcohol or drug abuse

Primary outcomes:
measure: AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac
timeFrame: 20 days
measure: Cmax of Diclofenac gel in tube/Cmax of oral Diclofenac
timeFrame: 20 days
measure: AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of oral Diclofenac
timeFrame: 20 days
measure: Cmax of Diclofenac gel in roll-on device/Cmax of oral Diclofenac
timeFrame: 20 days
Secondary outcomes:
measure: Cmin of Diclofenac gel in tube/Cmin of oral Diclofenac
timeFrame: 20 days
measure: Tmax of Diclofenac gel in tube/Tmax of oral Diclofenac
timeFrame: 20 days
measure: Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac
timeFrame: 20 days
measure: Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac
timeFrame: 20 days
measure: Cmax of Diclofenac gel in tube/Cmax of Diclofenac in Voltaren gel
timeFrame: 20 days
measure: Cmax of Diclofenac gel in roll-on device/Cmax of Diclofenac in Voltaren gel
timeFrame: 20 days
measure: Cmin of Diclofenac gel in tube/Cmin of Diclofenac in Voltaren gel
timeFrame: 20 days
measure: Cmin of Diclofenac gel in roll-on device/Cmin of Diclofenac in Voltaren gel
timeFrame: 20 days
measure: AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of Diclofenac in Voltaren gel
timeFrame: 20 days
measure: AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of Diclofenac in Voltaren gel
timeFrame: 20 days
measure: Tmax of Diclofenac gel in tube/Tmax of Diclofenac in Voltaren gel
timeFrame: 20 days
measure: Tmax of Diclofenac gel in roll-on device/Tmax of Diclofenac in Voltaren gel
timeFrame: 20 days
measure: Cmax of Menthol in gel/Cmax of Menthol reported in literature
timeFrame: 20 days
measure: Cmax of Menthol in roll-on device/Cmax of Menthol reported in literature
timeFrame: 20 days
measure: Cmin of Menthol in gel/Cmin of Menthol reported in literature
timeFrame: 20 days
measure: Cmin of Menthol in roll-on device/Cmin of Menthol reported in literature
timeFrame: 20 days
measure: Tmax of Menthol in gel/Tmax of Menthol reported in literature
timeFrame: 20 days
measure: Tmax of Menthol in roll-on device/Tmax of Menthol reported in literature
timeFrame: 20 days
measure: T1/2 of Menthol in gel/T1/2 of Menthol reported in literature
timeFrame: 20 days
measure: T1/2 of Menthol in roll-on device/T1/2 of Menthol reported in literature
timeFrame: 20 days
measure: AUC48-72 hrs of Menthol in gel/AUC48-72 hrs of Menthol reported in literature
timeFrame: 20 days
measure: AUC48-72 hrs of Menthol in roll-on device/AUC48-72 hrs of Menthol reported in literature
timeFrame: 20 days
measure: AUC48-72 hrs of Voltaren gel/AUC48-72 hrs of oral Diclofenac
timeFrame: 20 days
measure: Cmax of Voltaren gel/Cmax of oral Diclofenac
timeFrame: 20 days
measure: T1/2 of Diclofenac gel in tube/T1/2 of oral Diclofenac
timeFrame: 20 days
measure: T1/2 of Diclofenac gel in roll-on device/T1/2 of oral Diclofenac
timeFrame: 20 days
measure: T1/2 of Diclofenac gel in tube/T1/2 of Diclofenac in Voltaren gel
timeFrame: 20 days
measure: T1/2 of Diclofenac gel in roll-on device/T1/2 of Diclofenac in Voltaren gel
timeFrame: 20 days
measure: Adverse event monitoring
timeFrame: 27 days
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: