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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859377
• Other study ID #: V00498 TA 1 01
• Secondary ID: 2013-000732-96
• Status: Completed
• Phase: Phase 1
• First received: May 17, 2013
• Last updated: June 21, 2013
• Start date: May 2013
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• V0498 - A mg
Single oromucosal administration
• Ibuprofen
Single oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)		11 time points up to 10h after administration	No
Primary	Time of Maximum Concentration		11 time points up to 10h after administration	No
Primary	Area Under Curve (AUC0-72)		11 time points up to 10h after administration	No