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A Bioequivalence Study Of Ibuprofen 50mg/ml (laboratórios Pfizer Ltda) In The Oral Suspension Form. (B4371004)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01350596
First Posted: May 10, 2011
Last Update Posted: August 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
An open label, randomized, 2x2 crossover, single dose, phase 4 study to determine the pharmaceutical bioequivalence of ibuprofen 50mg/ml (laboratórios pfizer ltda) oral suspension versus alivium ® 50mg/ml (mantecorp indústria química e farmacêutica ltda.) Oral suspension, in healthy fasting volunteers.

Condition Intervention Phase
Healthy Drug: Alivium® Drug: Ibuprofen Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label, Randomized, 2x2 Crossover, Single Dose, Phase 4 Study To Determine The Pharmaceutical Bioequivalence Of Ibuprofen 50mg/Ml (Laboratórios Pfizer Ltda) Oral Suspension Versus Alivium ® 50mg/Ml (Mantecorp Indústria Química E Farmacêutica Ltda.) Oral Suspension, In Healthy Fasting Volunteers.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: May 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 8mL (50mg/mL) oral suspension of the Test Drug

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
  • 12-lead ECG demonstrating QTc> 450 msec at screening visit. If the QTc exceeds 450 msec, 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 hypersensitivity to Ibuprofen or chemically related compounds;
  • 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.
  • 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.
  • If volunteer presents any condition that prevents his or her participation in the study, according to the opinion of the investigator.
  • Volunteer with gastroduodenal ulcer, or previous or active gastrointestinal bleeding.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350596


Locations
Brazil
Pfizer Investigational Site
Aparecida de Goiania, Goias, Brazil, 74935-530
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01350596     History of Changes
Other Study ID Numbers: B4371004
ICF: PBIO027/11
First Submitted: May 6, 2011
First Posted: May 10, 2011
Last Update Posted: August 3, 2011
Last Verified: August 2011

Keywords provided by Pfizer:
Bioequivalence Study
Ibuprofen
Alivium

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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action