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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: V0498 - A mg; Drug: Ibuprofen

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, B-4000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sequence 1; Test Drug (V0498 - A mg) - Reference (Ibuprofen)	Drug: V0498 - A mg; Single oromucosal administration; Drug: Ibuprofen; Single oral administration
Other: Sequence 2; Reference (Ibuprofen) - Test drug(V0498 - A mg)	Drug: V0498 - A mg; Single oromucosal administration; Drug: Ibuprofen; Single oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pierre Fabre Medicament

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 17, 2013
• First Submitted That Met QC Criteria: May 17, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Estimate): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 21, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: V00498 TA 1 01; 2013-000732-96 (EudraCT Number)