Evaluation and Comparison of Systemic Exposure to Ibuprofen After Single Oromucosal Versus Oral Administrations

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: V0498 - A mg; Drug: Ibuprofen

• Registration Number: NCT01859377
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

The purpose of this study is to evaluate the systemic exposure to ibuprofen after single oromucosal administration of the test product V0498 and single oral administration of a reference product.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-17
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-21
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-21
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

• Healthy male subject aged 18 to 45 years (inclusive),
• 18.5 < or = Body Mass Index < or = 30 kg/m²,
• Non-smoker for at least 6 months
• Subject agreed to be registered in the Belgium national register "VIP Check International" for this study participation .

Exclusion Criteria

• Positive serology for Hepatitis B Virus antigens, Hepatitis C Virus or Human Immunodeficiency Virus 1 or 2 antibodies,
• Organic disorder likely to modify absorption, distribution or elimination of the medication,
• History of sensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) or to any of the excipients
• Subject who has donated blood within the past 3 months,
• Subject who has forfeited his freedom by administrative or legal award, or who is under guardianship or who has been admitted in a sanitary or social institution,
• Participation in another clinical trial in the previous month or subject still within the exclusion period of a previous clinical trial or is participating in another clinical trial,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	V0498 - A mg	Test Drug (V0498 - A mg) - Reference (Ibuprofen)
Sequence 2	V0498 - A mg	Reference (Ibuprofen) - Test drug(V0498 - A mg)
Sequence 1	Ibuprofen	Test Drug (V0498 - A mg) - Reference (Ibuprofen)
Sequence 2	Ibuprofen	Reference (Ibuprofen) - Test drug(V0498 - A mg)

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax)	11 time points up to 10h after administration
Time of Maximum Concentration	11 time points up to 10h after administration
Area Under Curve (AUC0-72)	11 time points up to 10h after administration