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OpenTrials
Completed

NCT Number: NCT01859377

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Liège, B-4000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

V0498 - A mg

Drug

Single oromucosal administration

Ibuprofen

Drug

Single oral administration

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: 11 time points up to 10h after administration

  2. Time of Maximum Concentration

    Time frame: 11 time points up to 10h after administration

  3. Area Under Curve (AUC0-72)

    Time frame: 11 time points up to 10h after administration

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 21, 2013
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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