Study to Test the Blood to See if a New Medicine is Likely to Provide Pain Relief Similar to a Product Already Sold in Stores

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01555476
First received: March 13, 2012
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

This study is designed to assess bioequivalence between one test and one reference formulation used for temporary relief of pain. The results will help decide if the new medicine is likely to provide pain relief similar to the product being sold.


Condition Intervention Phase
Pain
Drug: Ibuprofen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Bioequivalence Between an Ibuprofen Suspension and a Reference Formulation. A Study in Healthy Volunteers.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cmax [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    Maximum observed plasma concentration (Cmax), is the maximum (peak) concentration (amount of drug) measured in blood plasma after a dose administration.

  • AUCt [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    Area under the plasma concentration-vs.-time curve from start of drug administration until last measured concentration (AUCt), is a measure of how much of the drug reaches the bloodstream during the sampling period.


Secondary Outcome Measures:
  • AUC∞ [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    Area under the plasma concentration-vs.-time curve from start of drug administration and extrapolated to infinity (AUC∞), is a measure of how much of the drug ever reaches the bloodstream.

  • tmax [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    The time at which maximum concentration is reached (tmax)

  • Terminal Elimination Rate Constant (λz) [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    The terminal elimination rate constant (λz) describes the rate at which a drug is eliminated from the body.

  • t½ [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    Terminal half-life (t½) is the time required for the plasma concentration (as well as the amount of drug in the body) to fall by one-half.

  • Mean Residence Time (MRT) [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    Mean residence time (MRT) is the mean time a drug molecule resides in the body.


Enrollment: 32
Study Start Date: February 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A-IBU
A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits.
Drug: Ibuprofen
A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits
Other Name: Not yet marketed.
Active Comparator: B-IBU
A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits
Drug: Ibuprofen
A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits
Other Name: Nurofen for Children Six Plus

Detailed Description:

The study is a single dose, randomized, two-way crossover study in 32 healthy male and female volunteers, minimum of 14 of each gender. Two doses of study medication will be given as single doses on two separate treatment visits. A washout of at least 48 hours will separate the treatment visits. Each visit will include an overnight fast at the clinic and 19 blood samples drawn for pharmacokinetic analyses. Tolerability of the treatments will be evaluated in terms of reported and observed adverse events (AE).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy (per protocol-specified parameters) male or female subjects (14 of each gender) between the ages of 18 and 50 years, inclusive.
  • Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco for at least 12 months before screening visit of this study.
  • For females: if not postmenopausal, agrees to use a protocol-specified means of contraception or declared absence of sexual contact with a male partner during the study.
  • For males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study.
  • Body Mass Index (BMI) within protocol-specified parameters.
  • A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.

Exclusion Criteria:

  • Evidence or history of an acute or chronic medical or psychiatric condition, laboratory abnormality, or drug use that, in the judgment of the investigator or an authorized physician, may compromise subject safety or the interpretation of results.
  • Females: Pregnant or breast-feeding
  • Treatment with an investigational drug within 3 months preceding the first dose of study treatment.
  • History of regular alcohol consumption outside the protocol-specified allowances.
  • Donation or loss of blood within 3 months prior to the first treatment visit if the estimated lost blood volume equaled or exceeded 450 mL.
  • Relationship to persons involved directly with the conduct of the study, or their families.
  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: NCT01555476

Locations
Sweden
McNeil AB Clinical Pharmacology R&D
Lund, Sweden, 222 20
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT01555476     History of Changes
Other Study ID Numbers: IBUPAI1002, 2011-001570-26
Study First Received: March 13, 2012
Last Updated: July 6, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Pharmacokinetics

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 August 26, 2014