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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201238
• Other study ID #: 202188
• Secondary ID: RH02175
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2014
• Last updated: June 28, 2017
• Start date: October 1, 2014
• Est. completion date: November 21, 2014

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 21, 2014
• Est. primary completion date: November 21, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Diclofenac sodium
Diclofenac sodium
• Menthol
Menthol

Locations

Country	Name	City	State
United States	GSK Investigational Site	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac	Ratio of area under the plasma concentration time curve from 48-72 hrs (AUC48-72 hrs) of Diclofenac gel in tube and AUC48-72 hrs of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac	20 days
Primary	Cmax of Diclofenac gel in tube/Cmax of oral Diclofenac	Ratio of maximum plasma concentration (Cmax) of Diclofenac gel in tube and Cmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac	20 days
Primary	AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of oral Diclofenac	Ratio of AUC48-72 hrs of Diclofenac gel in roll-on device and AUC48-72 hrs of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac	20 days
Primary	Cmax of Diclofenac gel in roll-on device/Cmax of oral Diclofenac	Ratio of Cmax of Diclofenac gel in roll-on device and Cmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac	20 days
Secondary	Cmin of Diclofenac gel in tube/Cmin of oral Diclofenac	Ratio of minimum plasma concentration (Cmin) of Diclofenac gel in tube and Cmin of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac	20 days
Secondary	Tmax of Diclofenac gel in tube/Tmax of oral Diclofenac	Ratio of time to maximum plasma concentration (Tmax) of Diclofenac gel in tube and Tmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac	20 days
Secondary	Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac	Ratio of Cmin of Diclofenac gel in roll-on device and Cmin of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac	20 days
Secondary	Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac	Ratio of Tmax of Diclofenac gel in roll-on device and Tmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac	20 days
Secondary	Cmax of Diclofenac gel in tube/Cmax of Diclofenac in Voltaren gel	Ratio of Cmax of Diclofenac gel in tube and Cmax of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel	20 days
Secondary	Cmax of Diclofenac gel in roll-on device/Cmax of Diclofenac in Voltaren gel	Ratio of Cmax of Diclofenac gel in roll-on device and Cmax of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel	20 days
Secondary	Cmin of Diclofenac gel in tube/Cmin of Diclofenac in Voltaren gel	Ratio of Cmin of Diclofenac gel in tube and Cmin of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel	20 days
Secondary	Cmin of Diclofenac gel in roll-on device/Cmin of Diclofenac in Voltaren gel	Ratio of Cmin of Diclofenac gel in roll-on device and Cmin of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel	20 days
Secondary	AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of Diclofenac in Voltaren gel	Ratio of AUC48-72 hrs of Diclofenac gel in tube and AUC48-72 hrs of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel	20 days
Secondary	AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of Diclofenac in Voltaren gel	Ratio of AUC48-72 hrs of Diclofenac gel in roll-on device and AUC48-72 hrs of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel	20 days
Secondary	Tmax of Diclofenac gel in tube/Tmax of Diclofenac in Voltaren gel	Ratio of Tmax of Diclofenac gel in tube and Tmax of Voltaren during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel	20 days
Secondary	Tmax of Diclofenac gel in roll-on device/Tmax of Diclofenac in Voltaren gel	Ratio of Tmax of Diclofenac gel in roll-on device and Tmax of Voltaren during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel	20 days
Secondary	Cmax of Menthol in gel/Cmax of Menthol reported in literature	Ratio of Cmax of Menthol in tube and Cmax of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature	20 days
Secondary	Cmax of Menthol in roll-on device/Cmax of Menthol reported in literature	Ratio of Cmax of Menthol in roll-on device and Cmax of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature	20 days
Secondary	Cmin of Menthol in gel/Cmin of Menthol reported in literature	Ratio of Cmin of Menthol in tube and Cmin of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature	20 days
Secondary	Cmin of Menthol in roll-on device/Cmin of Menthol reported in literature	Ratio of Cmin of Menthol in roll-on device and Cmin of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature	20 days
Secondary	Tmax of Menthol in gel/Tmax of Menthol reported in literature	Ratio of Tmax of Menthol in tube and Tmax of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature	20 days
Secondary	Tmax of Menthol in roll-on device/Tmax of Menthol reported in literature	Ratio of Tmax of Menthol in roll-on device and Tmax of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature	20 days
Secondary	T1/2 of Menthol in gel/T1/2 of Menthol reported in literature	Ratio of half time elimination (T1/2) of Menthol in tube and T1/2 of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reporetd in literature	20 days
Secondary	T1/2 of Menthol in roll-on device/T1/2 of Menthol reported in literature	Ratio of T1/2 of Menthol in roll-on device and T1/2 of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature	20 days
Secondary	AUC48-72 hrs of Menthol in gel/AUC48-72 hrs of Menthol reported in literature	Ratio of AUC48-72 hrs of Menthol in gel and AUC48-72 hrs of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature	20 days
Secondary	AUC48-72 hrs of Menthol in roll-on device/AUC48-72 hrs of Menthol reported in literature	Ratio of AUC48-72 hrs of Menthol in roll-on device and AUC48-72 hrs of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature	20 days
Secondary	AUC48-72 hrs of Voltaren gel/AUC48-72 hrs of oral Diclofenac	Ratio of AUC48-72 hrs of Voltaren gel and AUC48-72 hrs of oral Diclofenac will assess systemic exposure of Voltaren gel as compared to oral Diclofenac	20 days
Secondary	Cmax of Voltaren gel/Cmax of oral Diclofenac	Ratio of Cmax of Voltaren gel and Cmax of oral Diclofenac will assess systemic exposure of Voltaren gel as compared to oral Diclofenac	20 days
Secondary	T1/2 of Diclofenac gel in tube/T1/2 of oral Diclofenac	Ratio of T1/2 of Diclofenac gel in tube and T1/2 of oral Diclofenac will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac	20 days
Secondary	T1/2 of Diclofenac gel in roll-on device/T1/2 of oral Diclofenac	Ratio of T1/2 of Diclofenac gel in roll-on device and T1/2 of oral Diclofenac will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac	20 days
Secondary	T1/2 of Diclofenac gel in tube/T1/2 of Diclofenac in Voltaren gel	Ratio of T1/2 of Diclofenac gel in tube and T1/2 of Voltaren gel will assess systemic exposure to Diclofenac from gel tube as compared to that from Voltaren gel	20 days
Secondary	T1/2 of Diclofenac gel in roll-on device/T1/2 of Diclofenac in Voltaren gel	Ratio of T1/2 of Diclofenac gel in roll-on device and T1/2 of Voltaren gel will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel	20 days
Secondary	Adverse event monitoring		27 days

External Links

•   Results for the study 202188 can be found on the GSK Clinical Study Register.