Pharmacokinetics of 3 Formulations of Ibuprofen Suppositories

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00921830
First received: June 15, 2009
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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).


Condition Intervention Phase
Healthy
Drug: ibuprofen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Single-dose, Randomised, Crossover Study to Compare the Rate and Extent of Absorption of Three Formulations of Ibuprofen in Healthy, Fasting Male and Female Volunteers

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Pharmacokinetic parameters, including AUC0-t and AUC0-∞ [ Time Frame: 14 samples over 12 hours in each period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters, including Cmax, tmax, t1/2 and Terminal Elimination Rate Constant [ Time Frame: 14 samples over 12 hours in each period ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: April 2004
Study Completion Date: November 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen
ibuprofen
Drug: ibuprofen
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.
Other Name: MOTRIN®

Detailed Description:

Ibuprofen is a widely used analgesic and antipyretic in adults and children. Two ibuprofen suppository formulations have been developed for pediatric use to facilitate dosing in younger age groups. This is a single-dose, balanced, randomised, three-period crossover study in healthy male and female adult volunteers. Each volunteer will receive a single dose of 50 mg ibuprofen as a suppository, a single dose of 200 mg ibuprofen as a suppository and a single oral dose of 200 mg ibuprofen (tablet). There will be 14 blood samples taken over 12 hours in each study period. Concentrations in plasma of ibuprofen and its S and R enantiomers will be measured using a validated chromatographic method. Standard pharmacokinetic parameters will be obtained and bioavailability on the basis of rate and extent of drug absorption will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Donation of blood or plasma within previous 90 days
  • Participation in a clinical trial in the previous 12 months in which a volume of blood exceeding 500 ml was donated
  • Any indication of current or previous abuse of alcohol, solvents or drugs
  • Treatment with a full or regular course of medication during the 28 days prior to the start of the study
  • Use of alcohol on study days or within 24 hours prior to commencement of each study period
  • Intake of grapefruit products within 7 days prior to study commencement
  • Intake of methylxanthine-containing beverages within 24 hours prior to each study period
  • Intake of quantities of methylxanthine or alcohol-containing beverages which, in the opinion of the Investigator are abnormal (habitually taking more than 5 cups or glasses of tea, coffee, cola, chocolate etc per day or habitually taking more than 20g alcohol/day)
  • Taking medication (prescription or proprietary) within 14 days prior to the study start. Paracetamol is allowed up to 72 hours prior to either study period. The oral contraceptive pill is allowed.
  • Failure to use adequate contraceptive measures; positive pregnancy test (female volunteers only)
  • Lactating/breastfeeding (female volunteers only)
  • Diet, which in the opinion of the Investigator, deviates from a normal diet (e.g. vegans)
  • Not able/not willing to give informed consent
  • Not able to be contacted in case of emergency.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921830

Locations
Ireland
Shandon Clinic
Cork, Co. Cork, Ireland
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Jerry Cottrell McNeil UK
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00921830     History of Changes
Other Study ID Numbers: SCO2203
Study First Received: June 15, 2009
Last Updated: October 4, 2011
Health Authority: Ireland: Irish Medicines Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
ibuprofen
healthy volunteers
bioavailability
pharmacokinetics
suppository

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 29, 2014