Inflammation and pain Inflammation and pain
Conditions
Interventions
Both the test group as the actual study consist of 2 periods during which
subjects will receive the study drug in Period 1 and the comparator drug in
Period 2, or vice versa. There will be 7 days be
Sponsors
The Mentholatum Company Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Sex: male or female; females may be of childbearing potential or of non childbearing potential. 2. Age: 18 to 65 years, inclusive, at screening. 3. Body mass index : 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening. 4. Weight: >=50 kg, at screening. 5. Status and race: healthy Caucasian subject.
Exclusion criteria
Exclusion criteria: 1. Employee of PRA or the Sponsor. 2. History of relevant drug and/or food allergies. 3. Suffering from, or with a history of, bronchial asthma or a significant cardiac or gastro-duodenal disease. 4. Having a significant skin disease at the application site (back). 5. Having a tattoo or excessive hair growth at the application site (back). 6. Smoking more than 5 cigarettes (or 1 cigar, 1 pipe, or an equivalent amount of nicotine products) daily, or unable to refrain from smoking from 48 hours (2 days) prior to each admission to the clinical research center until discharge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the bioequivalence of Mentholatum 10% w/w Ibuprofen Gel and Ibuleve 10% w/w Ibuprofen Gel in healthy subjects using AUC0-t, Cmax, and comparability of tmax of (RS) ibuprofen as primary endpoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the bioequivalence of Mentholatum 10% w/w Ibuprofen Gel and Ibuleve 10% w/w Ibuprofen Gel using AUC0-t and Cmax of the (S) enantiomer of ibuprofen in healthy subjects. - To compare the safety and tolerability of Mentholatum 10% w/w Ibuprofen Gel and Ibuleve 10% w/w Ibuprofen Gel in healthy subjects. | — |
Countries
Netherlands
Outcome results
None listed