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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 Diclofenac

Cmax 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 Diclofenac

Tmax 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

Page last updated: August 23, 2015

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