A Pharmacokinetics Study Comparing Systemic Exposure of Topical Diclofenac/Menthol Gels Versus Voltaren Gel and Oral Diclofenac Sodium in Healthy Volunteers at Steady State
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants aged 18 to 50 years
- •Body mass index between 19-28 (kg/m2)
排除标准
- •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
研究组 & 干预措施
Diclofenac sodium/menthol gel (in tube)
1% diclofenac sodium plus 3% menthol gel (in 30g aluminium tube). Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day
干预措施: Diclofenac sodium (Drug)
Diclofenac sodium/menthol gel (in tube)
1% diclofenac sodium plus 3% menthol gel (in 30g aluminium tube). Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day
干预措施: Menthol (Drug)
Diclofenac sodium/menthol gel (in roll-on device)
1% diclofenac sodium plus 3% menthol gel (in roll-on applicator device supplied in 30g plastic bottles). Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day
干预措施: Diclofenac sodium (Drug)
Diclofenac sodium/menthol gel (in roll-on device)
1% diclofenac sodium plus 3% menthol gel (in roll-on applicator device supplied in 30g plastic bottles). Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day
干预措施: Menthol (Drug)
Diclofenac sodium tablets
50mg diclofenac sodium tablets administered orally, three times daily for three consecutive days with 6h between adjacent doses on the same day
干预措施: Diclofenac sodium (Drug)
Voltaren gel
Voltaren gel supplied in 100g aluminium tube. Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day
干预措施: Diclofenac sodium (Drug)
结局指标
主要结局
AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac
时间窗: 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
Cmax of Diclofenac gel in tube/Cmax of oral Diclofenac
时间窗: 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
AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of oral Diclofenac
时间窗: 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
Cmax of Diclofenac gel in roll-on device/Cmax of oral Diclofenac
时间窗: 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
次要结局
- AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of Diclofenac in Voltaren gel(20 days)
- Tmax of Diclofenac gel in tube/Tmax of Diclofenac in Voltaren gel(20 days)
- Tmax of Diclofenac gel in roll-on device/Tmax of Diclofenac in Voltaren gel(20 days)
- Tmax of Diclofenac gel in tube/Tmax of oral Diclofenac(20 days)
- Cmin of Diclofenac gel in roll-on device/Cmin of Diclofenac in Voltaren gel(20 days)
- Cmin of Diclofenac gel in tube/Cmin of oral Diclofenac(20 days)
- Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac(20 days)
- Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac(20 days)
- Cmax of Diclofenac gel in tube/Cmax of Diclofenac in Voltaren gel(20 days)
- Cmax of Diclofenac gel in roll-on device/Cmax of Diclofenac in Voltaren gel(20 days)
- Cmin of Diclofenac gel in tube/Cmin of Diclofenac in Voltaren gel(20 days)
- Cmax of Menthol in gel/Cmax of Menthol reported in literature(20 days)
- AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of Diclofenac in Voltaren gel(20 days)
- Tmax of Menthol in gel/Tmax of Menthol reported in literature(20 days)
- Cmax of Menthol in roll-on device/Cmax of Menthol reported in literature(20 days)
- Cmin of Menthol in gel/Cmin of Menthol reported in literature(20 days)
- T1/2 of Menthol in roll-on device/T1/2 of Menthol reported in literature(20 days)
- AUC48-72 hrs of Menthol in gel/AUC48-72 hrs of Menthol reported in literature(20 days)
- Cmax of Voltaren gel/Cmax of oral Diclofenac(20 days)
- T1/2 of Diclofenac gel in tube/T1/2 of Diclofenac in Voltaren gel(20 days)
- T1/2 of Diclofenac gel in roll-on device/T1/2 of Diclofenac in Voltaren gel(20 days)
- Adverse event monitoring(27 days)
- Cmin of Menthol in roll-on device/Cmin of Menthol reported in literature(20 days)
- Tmax of Menthol in roll-on device/Tmax of Menthol reported in literature(20 days)
- AUC48-72 hrs of Menthol in roll-on device/AUC48-72 hrs of Menthol reported in literature(20 days)
- T1/2 of Menthol in gel/T1/2 of Menthol reported in literature(20 days)
- AUC48-72 hrs of Voltaren gel/AUC48-72 hrs of oral Diclofenac(20 days)
- T1/2 of Diclofenac gel in tube/T1/2 of oral Diclofenac(20 days)
- T1/2 of Diclofenac gel in roll-on device/T1/2 of oral Diclofenac(20 days)