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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Alivium®; Drug: Ibuprofen

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Goias
    • Aparecida de Goiania, Goias, Brazil, CEP:74935-530
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference Drug	Drug: Alivium®; 400mg of Ibuprofen equivalent to 8mL (50mg/mL) oral suspension of the Reference Drug
Active Comparator: Test Drug	Drug: Ibuprofen; 400mg of Ibuprofen equivalent to 10mL (40mg/mL) oral suspension of the Test Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug	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))	Up to 16h

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve from time zero to infinity of Test Drug and Reference Drug (AUC(0-inf))	Up to 16h
Time to peak concentration of Test Drug and Reference Drug (Tmax)	Up to 16h
Half-life of Test Drug and Reference Drug (T1/2)	Up to 16h
Elimination rate constant (K el)	Up to 16h
Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity	Up to 16h

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: November 3, 2011
• First Submitted That Met QC Criteria: November 3, 2011
• First Posted (Estimate): November 8, 2011

Study Record Updates

• Last Update Posted (Estimate): February 8, 2012
• Last Update Submitted That Met QC Criteria: February 7, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Ibuprofen; Relative Bioavailability Study; Alivium
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: B4371005; ICF:PBDS013/11