A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01316978
First received: March 15, 2011
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

This study is designed to assess bioequivalence between one test and two reference formulations used for treatment of headaches and temporary relief of pain.


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: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: A Single-Dose, Randomised, Crossover Bioequivalence Study to Compare the Rate and Extent of Absorption of a Test Formulation of Ibuprofen Fast Melt Orodispersible Tablet Versus Two Reference Formulations in Healthy Volunteers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Maximum Observed Plasma Concentration [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)

  • Bioavailability [AUC(0-t)] [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    Bioavailability [AUC(0-t)] is a measure of how much of the drug reaches the person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour * nanograms (ng) per milliliter (mL).


Secondary Outcome Measures:
  • Bioavailability Extrapolated to Infinity [AUC (0-∞)] [ Time Frame: 12 hours post-dose ] [ Designated as safety issue: No ]
    Bioavailability Extrapolated to Infinity [AUC (0-∞)] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-∞) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-∞).

  • Time of Maximum Concentration [ 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 [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose

  • Terminal Phase Plasma Half-Life [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose.


Enrollment: 30
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Experimental Ibuprofen
Drug: Ibuprofen
A single 2 x 100 mg dose of an experimental Ibuprofen Fast Melt Orodispersible Tablet administered orally, with a 7-day washout between visits
Other Name: Not yet marketed
Active Comparator: Nurofen
Nurofen Meltlets Orodispersible Tablet
Drug: Ibuprofen
A single 200 mg Nurofen Meltlets Orodispersible Tablet administered orally, with a 7-day washout between visits
Other Name: Nurofen Meltlets Orodispersible Tablet
Active Comparator: Motrin
Junior Strength Motrin Chewable Tablet
Drug: Ibuprofen
A single 2 x 100 mg dose of Junior Strength Motrin Chewable Tablet administered orally, with a 7-day washout between visits
Other Name: Junior Strength Motrin Chewable Tablet

Detailed Description:

The study is a single dose, randomized, three-way crossover study in 30 healthy subjects, with equal numbers of males and females (minimum of 13 of either gender). Drop-outs will not be replaced. The three doses of medication given in the study (a single dose in each of the three study periods) will each be separated by a washout period of at least 7 calendar days. In each study period, eighteen (18) blood samples for pharmacokinetic analysis will be taken over 12 hours. Blood samples will be centrifuged and concentrations of ibuprofen (R-enantiomer and S-enantiomer) in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data [R-enantiomer, S-enantiomer and total (sum of both enantiomers)]. The rate and extent of absorption of the formulations will be compared.

  Eligibility

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

Inclusion Criteria:

  • Male or female subjects (equal numbers of males and females)
  • Volunteers aged of at least 18 years but not older than 55 years
  • Subjects will have a Body Mass Index (BMI) greater than or equal to 18.5 and below 30 kg/m2; and a total body weight >50 kg
  • Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
  • Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
  • Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)
  • Has signed and dated the 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

Exclusion Criteria:

  • Seated pulse rate below 45 bpm or higher than 90 bpm at screening
  • Seated blood pressure below 90/60 mmHg or higher than 140/90 mmHg at screening
  • Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson subsidiaries; and the families of each)
  • Presence of any tongue piercings
  • Presence of braces
  • Females who are pregnant or are lactating
  • Females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
  • Females who are pregnant according to a positive serum pregnancy test
  • Any medical history or condition, or use of any drug or medication, that the investigator determines could compromise subject safety or the evaluation of results.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316978

Locations
Canada, Quebec
Algorithme Pharma Inc.
Mount-Royal, Quebec, Canada, H3P 3P1
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: NCT01316978     History of Changes
Other Study ID Numbers: IBUPAI1001
Study First Received: March 15, 2011
Last Updated: July 6, 2012
Health Authority: Canada: Health Canada

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 April 23, 2014