A Relative BioavailabilityStudy Of Ibuprofen 40mg/ml (laboratórios Pfizer Ltda) In The Oral Suspension Form.
NCT01466517
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 70 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |