Healthy Volunteers
Conditions
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.
Interventions
DRUGIbuprofen
Single oral administration
DRUGV0498 - A mg
Single oromucosal administration
Sponsors
Pierre Fabre Medicament
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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,
Design outcomes
Primary
| 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 |
Countries
Belgium
Outcome results
None listed