Status:
COMPLETED
Evaluation and Comparison of Systemic Exposure to Ibuprofen After Single Oromucosal Versus Oral Administrations
Lead Sponsor:
Pierre Fabre Medicament
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy male subject aged 18 to 45 years (inclusive),
- 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
- 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,
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01859377
Start Date
May 1 2013
End Date
June 1 2013
Last Update
June 24 2013
Active Locations (1)
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1
Liège, Belgium, B-4000