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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aparecida de Goiania, Goias, CEP:74935-530 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01466517
Pfizer
Completed
A Relative BioavailabilityStudy Of Ibuprofen 40mg/ml (laboratórios Pfizer Ltda) In The Oral Suspension Form.

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A Relative BioavailabilityStudy Of Ibuprofen 40mg/ml (laboratórios Pfizer Ltda) In The Oral Suspension Form.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Alivium®
    400mg of Ibuprofen equivalent to 8mL (50mg/mL) oral suspension of the Reference Drug
    Other Name: Not Specified
  • Drug: Ibuprofen
    400mg of Ibuprofen equivalent to 10mL (40mg/mL) oral suspension of the Test Drug
    Other Name: Not Specified
  • Active Comparator: Reference Drug
    Intervention: Drug: Alivium®
  • Active Comparator: Test Drug
    Intervention: Drug: Ibuprofen
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
November 2011
November 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01466517
B4371005
ICF:PBDS013/11
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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