Expired Study
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Buffalo, New York 14202


Purpose:

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.


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


NCT ID:

NCT02201238


Primary Contact:

Study Director
GSK Clinical Trials
GlaxoSmithKline


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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