NCT01859377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2013

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

1 month

First QC Date

May 17, 2013

Last Update Submit

June 21, 2013

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Sequence 1

OTHER

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

Drug: V0498 - A mgDrug: Ibuprofen

Sequence 2

OTHER

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

Drug: V0498 - A mgDrug: Ibuprofen

Interventions

V0498 - A mgDRUG

Single oromucosal administration

Sequence 1Sequence 2
IbuprofenDRUG

Single oral administration

Sequence 1Sequence 2

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subject aged 18 to 45 years (inclusive),
  • \< 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 .

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Liège, B-4000, Belgium

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2013

First Posted

May 21, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 24, 2013

Record last verified: 2013-06

Locations

BE(1)