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A Relative BioavailabilityStudy Of Ibuprofen 40mg/ml (laboratórios Pfizer Ltda) In The Oral Suspension Form. (B4371005)

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ClinicalTrials.gov Identifier: NCT01466517
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : February 8, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 3, 2011
First Posted Date  ICMJE November 8, 2011
Last Update Posted Date February 8, 2012
Study Start Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
  • Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug [ Time Frame: Up to 16h ]
  • Area under the plasma concentration versus time curve from time zero to the last measurable concentration of Test Drug and Reference Drug (AUC(0-tlast)) [ Time Frame: Up to 16h ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
  • Area under the plasma concentration versus time curve from time zero to infinity of Test Drug and Reference Drug (AUC(0-inf)) [ Time Frame: Up to 16h ]
  • Time to peak concentration of Test Drug and Reference Drug (Tmax) [ Time Frame: Up to 16h ]
  • Half-life of Test Drug and Reference Drug (T1/2) [ Time Frame: Up to 16h ]
  • Elimination rate constant (K el) [ Time Frame: Up to 16h ]
  • Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity [ Time Frame: Up to 16h ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Relative BioavailabilityStudy Of Ibuprofen 40mg/ml (laboratórios Pfizer Ltda) In The Oral Suspension Form.
Official Title  ICMJE A Phase IV, Open Label, Randomized, Two-Way Crossover, Single Dose Study To Determine The Relative Bioavailability Of Ibupirac 40 mg/ml (Laboratorios Pfizer LTDA) Oral Suspension Form Versus Alivium® 50mg/ml (Mantecorp Industria Quimicae Farmaceutica LTDA.) Oral Suspension Form, Under Fasted Conditions In Healthy Volunteers.
Brief Summary A PHASE IV, OPEN LABEL, RANDOMIZED, TWO-WAY CROSSOVER, SINGLE DOSE STUDY TO DETERMINE THE RELATIVE BIOAVAILABILITY OF IBUPIRAC 40MG/ML (LABORATÓRIOS PFIZER LTDA) ORAL SUSPENSION FORM VERSUS ALIVIUM® 50MG/ML (MANTECORP INDÚSTRIA QUÍMICA E FARMACÊUTICA LTDA.) ORAL SUSPENSION FORM, UNDER FASTED CONDITIONS IN HEALTHY VOLUNTEERS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Alivium®
    400mg of Ibuprofen equivalent to 8mL (50mg/mL) oral suspension of the Reference Drug
  • Drug: Ibuprofen
    400mg of Ibuprofen equivalent to 10mL (40mg/mL) oral suspension of the Test Drug
Study Arms  ICMJE
  • Active Comparator: Reference Drug
    Intervention: Drug: Alivium®
  • Active Comparator: Test Drug
    Intervention: Drug: Ibuprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2012)
70
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2011)
24
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy 18 to 55 years old male or female subjects (Healthy is defined as absence of clinically relevant abnormalities identified by detailed medical history, complete physical examination, including blood pressure and heart rate measurements, 12-lead ECG and clinical laboratory tests).
  • Volunteers' BMI - Body Mass Index must range from 18.5 to 24.9 (Dietary Guidelines for Americans), however, it can range to 15% of the upper limit (18.5 to 28.63) and total body weight >50kg.
  • Signed and dated Informed Consent Form by the subject or legally acceptable representative. If subject and/or legally acceptable representative is unable to read the Informed Consent Form, an impartial witness may sign it.
  • Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

  • Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic clinically significant disease (including drug allergies, except for seasonal allergies, asymptomatic, untreated at the time of dosing).
  • Any condition that may possibly affect the drug absorption (e.g. gastrectomy).
  • Volunteer presenting a drug abuse history [patients making use of marijuana and hashish will be excluded if they used these drugs in less than three months before the medical appointment, and volunteers who have used drugs such as cocaine, phencyclidine (PCP), crack and heroin, will be excluded if they used them in less than one year before the medical appointment].
  • A positive drug test in urine (Methamphetamine, Opiate, Morphine, Marijuana, Cannabis, Amphetamine, Cocaine, Benzodiazepine, and Benzoylecgonine) or a positive test for alcohol before admission during periods 1 and 2.
  • History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 serving = 150 mL of wine or 360 mL of beer or 45 mL of concentrated liquor) within 6 months from selection.
  • If volunteer have participated in any experimental study or have taken any experimental drug within 6 months prior to baseline (ANVISA: RDC Resolution No. 34, June 3, 2008).
  • Blood Pressure at screenning on a supine position ≥140 mm Hg (sistolic) or ≥90 mm Hg (diastolic), ina single measure (confirmed by a single measure repeated, if necessary) after at least 5 minutes of rest.
  • 12-lead ECG demonstrating QTc> 450 msec or QRS interval>120msec at screening visit. If the QTc exceeds 450 msec or QRS interval exceeds 120ms, the ECG should be repeated twice and the average of the three QTc values should be used to determine patient's eligibility.
  • Pregnant or breastfeeding women, women of childbearing potential who are unwilling or unable to use a non-hormonal acceptable contraception method, as described in this protocol, from at least 14 days before the first dose of study medication.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) before the first dose of study medication. Phytotherapic medicine and phytotherapic supplements should be discontinued 28 days before the first dose of study medication. With one exception, acetaminophen/paracetamol can be used at doses of 1 g/day. The limited use of nonprescription medications not considered as affecting the patient's safety or the general study results may be allowed on a case by case basis after sponsor's approval.
  • Blood donation of approximately 500 mL within 3 months before dosage.
  • Known hypersensitivityto Ibuprofen or chemically related compounds;
  • - Sensitivity History to heparin or heparin-induced thrombocytopenia.
  • Unwillingness or inability to comply with the Lifestyle Guidelines described in this protocol.
  • Other psychiatric or severe acute or clinically chronic condition or laboratory abnormality that may increase the risk associated with participation in the study or administration of investigational product, or which may interfere with the interpretation of study results and, in the opinion of the investigator, would make the patient inadequate to enter this study.
  • A positive beta HCG test in women.
  • Volunteers that are members of the Clinical Research Center or their relatives or Volunteers that are Pfizer employes direcly envolved on study conduction
  • If volunteer presents any condition that prevents his or her participation in the study, according to the opinion of the investigator.
  • Volunteers in whom acetylsalicylic acid, iodate and other Nonsteroidal anti-inflammatory drugs have induced asthma, rhinitis, urticaria, nasal polyps, angioedema, bronchospasm and other symptoms of allergic or anaphylactic reactions.
  • Volunteer with gastroduodenal ulcer, or previous or active gastrointestinal bleeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01466517
Other Study ID Numbers  ICMJE B4371005
ICF:PBDS013/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP