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Completed

NCT Number: NCT02201238

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Buffalo, New York, 14202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac Sodium

Drug

Diclofenac sodium

Menthol

Drug

Menthol

Primary outcomes

  1. AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac

    Time frame: 20 days

    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

  2. Cmax of Diclofenac gel in tube/Cmax of oral Diclofenac

    Time frame: 20 days

    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

  3. AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of oral Diclofenac

    Time frame: 20 days

    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

  4. Cmax of Diclofenac gel in roll-on device/Cmax of oral Diclofenac

    Time frame: 20 days

    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

Secondary outcomes

  1. Cmin of Diclofenac gel in tube/Cmin of oral Diclofenac

    Time frame: 20 days

    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

  2. Tmax of Diclofenac gel in tube/Tmax of oral Diclofenac

    Time frame: 20 days

    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

  3. Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac

    Time frame: 20 days

    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

  4. Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac

    Time frame: 20 days

    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

  5. Cmax of Diclofenac gel in tube/Cmax of Diclofenac in Voltaren gel

    Time frame: 20 days

    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

  6. Cmax of Diclofenac gel in roll-on device/Cmax of Diclofenac in Voltaren gel

    Time frame: 20 days

    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

  7. Cmin of Diclofenac gel in tube/Cmin of Diclofenac in Voltaren gel

    Time frame: 20 days

    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

  8. Cmin of Diclofenac gel in roll-on device/Cmin of Diclofenac in Voltaren gel

    Time frame: 20 days

    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

  9. AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of Diclofenac in Voltaren gel

    Time frame: 20 days

    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

  10. AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of Diclofenac in Voltaren gel

    Time frame: 20 days

    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

  11. Tmax of Diclofenac gel in tube/Tmax of Diclofenac in Voltaren gel

    Time frame: 20 days

    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

  12. Tmax of Diclofenac gel in roll-on device/Tmax of Diclofenac in Voltaren gel

    Time frame: 20 days

    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

  13. Cmax of Menthol in gel/Cmax of Menthol reported in literature

    Time frame: 20 days

    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

  14. Cmax of Menthol in roll-on device/Cmax of Menthol reported in literature

    Time frame: 20 days

    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

  15. Cmin of Menthol in gel/Cmin of Menthol reported in literature

    Time frame: 20 days

    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

  16. Cmin of Menthol in roll-on device/Cmin of Menthol reported in literature

    Time frame: 20 days

    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

  17. Tmax of Menthol in gel/Tmax of Menthol reported in literature

    Time frame: 20 days

    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

  18. Tmax of Menthol in roll-on device/Tmax of Menthol reported in literature

    Time frame: 20 days

    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

  19. T1/2 of Menthol in gel/T1/2 of Menthol reported in literature

    Time frame: 20 days

    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. T1/2 of Menthol in roll-on device/T1/2 of Menthol reported in literature

    Time frame: 20 days

    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

  21. AUC48-72 hrs of Menthol in gel/AUC48-72 hrs of Menthol reported in literature

    Time frame: 20 days

    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

  22. AUC48-72 hrs of Menthol in roll-on device/AUC48-72 hrs of Menthol reported in literature

    Time frame: 20 days

    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

  23. AUC48-72 hrs of Voltaren gel/AUC48-72 hrs of oral Diclofenac

    Time frame: 20 days

    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

  24. Cmax of Voltaren gel/Cmax of oral Diclofenac

    Time frame: 20 days

    Ratio of Cmax of Voltaren gel and Cmax of oral Diclofenac will assess systemic exposure of Voltaren gel as compared to oral Diclofenac

  25. T1/2 of Diclofenac gel in tube/T1/2 of oral Diclofenac

    Time frame: 20 days

    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

  26. T1/2 of Diclofenac gel in roll-on device/T1/2 of oral Diclofenac

    Time frame: 20 days

    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

  27. T1/2 of Diclofenac gel in tube/T1/2 of Diclofenac in Voltaren gel

    Time frame: 20 days

    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

  28. T1/2 of Diclofenac gel in roll-on device/T1/2 of Diclofenac in Voltaren gel

    Time frame: 20 days

    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

  29. Adverse event monitoring

    Time frame: 27 days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 28, 2014
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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