NCT00921830

Brief Summary

The purpose of this study is to compare the pharmacokinetic and bioavailability characteristics of two test formulations of ibuprofen for rectal administration with the profile of a marketed reference formulation of ibuprofen 200 mg (for oral administration).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2004

Typical duration for phase_1 healthy

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

April 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

3 months

First QC Date

June 15, 2009

Last Update Submit

October 4, 2011

Conditions

Healthy

Keywords

ibuprofenhealthy volunteersbioavailabilitypharmacokineticssuppository

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters, including AUC0-t and AUC0-∞

    14 samples over 12 hours in each period

Secondary Outcomes (1)

  • Pharmacokinetic parameters, including Cmax, tmax, t1/2 and Terminal Elimination Rate Constant

    14 samples over 12 hours in each period

Study Arms (1)

Ibuprofen

EXPERIMENTAL

ibuprofen

Drug: ibuprofen

Interventions

ibuprofenDRUG

Each subject will receive single doses of (i) ibuprofen 50 mg suppository (ii) ibuprofen 200 mg suppository and (iii) ibuprofen 200 mg tablet in 3 separate dosing periods. Doses will be administered after an overnight fast.

Also known as: MOTRIN®
Ibuprofen

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female volunteers aged between 18 and 55 years
  • BMI \< 27 kg/m2
  • Non-smokers, or smokers of less than 10 cigarettes per day
  • Clinically normal vital signs
  • Clinically normal medical history
  • Clinically normal findings on physical examination
  • Clinically normal findings for haematology and clinical chemistry of blood and urine or showing clinically insignificant deviations only
  • Screening results for drug abuse (taken within 14 days of study start) must be negative for opiates, cannabinoids, amphetamines, methamphetamine, benzodiazepines and cocaine
  • HIV and Hepatitis B and C tests, taken within previous 14 days of study start, must be negative
  • Appropriate use of an effective method of contraception (female volunteers only). Use of the oral contraceptive pill is permitted
  • Ability to comprehend and communicate effectively with the Investigator and staff
  • Ability to give written informed consent
  • Electrocardiogram recording (12-lead) within the normal range

You may not qualify if:

  • History of peptic ulcer or gastrointestinal bleeding
  • Resting heart rate outside the range 50 - 90 beats per minute or exhibiting any clinically significant degree of heart block
  • Resting, seated blood pressure less than 100/60 (90/50 for females) or greater than 140/90 mmHg
  • Clinically significant electrolyte imbalance
  • Evidence of clinically significant cardiovascular, haematological, hepatic, gastrointestinal, renal, respiratory, neurological, or psychiatric disease
  • History of medication with any psycho-pharmacologically active agents within the last five years (other than occasional night sedatives)
  • Gastric bleeding or history of allergies to NSAIDs
  • History of psychiatric illness or clinical treatment for psychiatric illness within the last five years
  • History of epilepsy
  • History of significant drug or drug related hypersensitivity/intolerance or food allergies
  • Illness within 14 days prior to start of study
  • Hospitalisation within the previous 3 months for major surgery or significant medical illness (at the discretion of the Investigator)
  • Mental handicap as defined by clinical evaluation
  • Tobacco smoking of more than 10 cigarettes per day
  • Participation in a clinical drug study in which blood was taken within 16 weeks prior to the start of the study
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandon Clinic

Cork, Co. Cork, Ireland

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Jerry Cottrell

    McNeil UK

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

April 1, 2004

Primary Completion

July 1, 2004

Study Completion

November 1, 2004

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

IE(1)