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

Pierre Fabre

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Ibuprofen; Drug: V0498 - A mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01859377

V00498 TA 1 01

2013-000732-96 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Sequence 1

Other group

Description:

Test Drug (V0498 - A mg) - Reference (Ibuprofen)

Treatment:

Drug: Ibuprofen

Drug: V0498 - A mg

Sequence 2

Other group

Description:

Reference (Ibuprofen) - Test drug(V0498 - A mg)

Treatment:

Drug: Ibuprofen

Drug: V0498 - A mg