Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium

• Status: Completed
• Trial end date: 2014-11-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Diclofenac; Menthol

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