Randomized, Blinded, 2 stage, 2-way Crossover Bioequivalence Study of Mentholatum 10% w/w Ibuprofen Gel and Ibuleve 10% w/w Ibuprofen Gel Administered as a Single Application of 125 mg in Healthy Subjects

Completed

• Conditions: Inflammation and pain

• Registration Number: NL-OMON51126
• Lead Sponsor: The Mentholatum Company Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-02-03
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 54

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To demonstrate the bioequivalence of Mentholatum 10% w/w Ibuprofen Gel and<br /><br>Ibuleve 10% w/w Ibuprofen Gel in healthy subjects using AUC0-t, Cmax, and<br /><br>comparability of tmax of (RS) ibuprofen as primary endpoints.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To evaluate the bioequivalence of Mentholatum 10% w/w Ibuprofen Gel and<br /><br>Ibuleve 10% w/w Ibuprofen Gel using AUC0-t and Cmax of the (S) enantiomer of<br /><br>ibuprofen in healthy subjects.<br /><br>- To compare the safety and tolerability of Mentholatum 10% w/w Ibuprofen Gel<br /><br>and Ibuleve 10% w/w Ibuprofen Gel in healthy subjects.</p><br>