Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Diclofenac sodium (Drug); Menthol (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral DiclofenacCmax of Diclofenac gel in tube/Cmax of oral Diclofenac AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of oral Diclofenac Cmax of Diclofenac gel in roll-on device/Cmax of oral Diclofenac
Secondary outcome: Cmin of Diclofenac gel in tube/Cmin of oral DiclofenacTmax of Diclofenac gel in tube/Tmax of oral Diclofenac Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac Cmax of Diclofenac gel in tube/Cmax of Diclofenac in Voltaren gel Cmax of Diclofenac gel in roll-on device/Cmax of Diclofenac in Voltaren gel Cmin of Diclofenac gel in tube/Cmin of Diclofenac in Voltaren gel Cmin of Diclofenac gel in roll-on device/Cmin of Diclofenac in Voltaren gel AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of Diclofenac in Voltaren gel AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of Diclofenac in Voltaren gel Tmax of Diclofenac gel in tube/Tmax of Diclofenac in Voltaren gel Tmax of Diclofenac gel in roll-on device/Tmax of Diclofenac in Voltaren gel Cmax of Menthol in gel/Cmax of Menthol reported in literature Cmax of Menthol in roll-on device/Cmax of Menthol reported in literature Cmin of Menthol in gel/Cmin of Menthol reported in literature Cmin of Menthol in roll-on device/Cmin of Menthol reported in literature Tmax of Menthol in gel/Tmax of Menthol reported in literature Tmax of Menthol in roll-on device/Tmax of Menthol reported in literature T1/2 of Menthol in gel/T1/2 of Menthol reported in literature T1/2 of Menthol in roll-on device/T1/2 of Menthol reported in literature AUC48-72 hrs of Menthol in gel/AUC48-72 hrs of Menthol reported in literature AUC48-72 hrs of Menthol in roll-on device/AUC48-72 hrs of Menthol reported in literature AUC48-72 hrs of Voltaren gel/AUC48-72 hrs of oral Diclofenac Cmax of Voltaren gel/Cmax of oral Diclofenac T1/2 of Diclofenac gel in tube/T1/2 of oral Diclofenac T1/2 of Diclofenac gel in roll-on device/T1/2 of oral Diclofenac T1/2 of Diclofenac gel in tube/T1/2 of Diclofenac in Voltaren gel T1/2 of Diclofenac gel in roll-on device/T1/2 of Diclofenac in Voltaren gel Adverse event monitoring
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Investigational Site, Buffalo, New York 14202, United States
Additional Information
Starting date: October 2014
Last updated: February 26, 2015
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