A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic (Fever Reduction) Effects in Healthy Male Volunteers
NCT02761980
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
1. Healthy male subjects who, at the time of screening, are between 18 and 55 years of age, inclusive.
2. The subject must have a normal, stable body temperature at Screening and on Day 0.
3. Body Mass Index (BMI) of 17.5 to 37.0 kg/m2; and a total body weight 50 kg (110 lbs) at Screening.
4. The subject has demonstrably adequate veins, by visual inspection, for IV catheter insertion.
1. Evidence or history of clinically significant laboratory abnormality, hematological,
renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (excluding untreated, asymptomatic, seasonal allergies at the time
of dosing) within the last 5 years that may increase the risk associated with study
participation.
2. Subjects with any gastrointestinal disorders (eg, gastrectomy, tracheostomy,
esophageal surgeries, short gut syndrome, peptic ulcer disease, known or suspected
obstructive disease, previous gastrointestinal surgery, felinization of the
esophagus, hypomotility of the gastrointestinal track) that could affect the
absorption, metabolism, or excretion of the study medication or affect the results of
the ingestible thermometer.
3. Subjects at risk for excessive bleeding.
4. Subjects with a history of nasal polyps, angioedema, or significant or actively
treated bronchospastic disease.
5. Screening supine blood pressure ≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg
(diastolic), following at least 5 minutes of supine rest.
6. Screening supine 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec
at Screening and on Day 1 prior to RSE administration.
7. The subject has a history of recurrent or acute or chronic infections of any type or
any findings suggestive of occult infection, such as tuberculosis, sinusitis, urinary
tract infection, respiratory tract or dental (abscess) infection, etc., or those with
a positive QuantiFERON Tuberculosis, Hepatitis B surface antigen, Hepatitis C
antibody, and/or Human immunodeficiency virus (HIV) test at Screening.
8. Subjects who have experienced cold/flu symptoms (ie, runny nose, cough, and/or fever)
within 2 weeks prior to the first administration of study treatments.
9. Subjects with a reduction in heart rate to ≤50 beats per minute or deemed to be at
high risk of syncope and/or hypotension per the clinical judgment of the investigator
following a carotid sinus massage procedure.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Knoxville, Tennessee
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male Volunteers | ||||
Official Title ICMJE | A Phase 3, Double-blind, Randomized, Placebo-controlled, Full Factorial, Safety And Efficacy Study Comparing The Antipyretic Effects Of A Single Oral Dose Of Ibuprofen (Ibu) 250 Mg/ Acetaminophen (Apap) 500 Mg Caplets To Ibu 250 Mg And Apap 500 Mg Caplets In Healthy Male Volunteers With Fever Induced By An Endotoxin | ||||
Brief Summary | This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with fever. Results for the Fixed Dose Combination product will be compared to the individual components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||
Condition ICMJE | Fever | ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE |
| ||||
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 | 290 | ||||
Original Estimated Enrollment ICMJE | 230 | ||||
Actual Study Completion Date ICMJE | December 6, 2017 | ||||
Actual Primary Completion Date | December 6, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
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 | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02761980 | ||||
Other Study ID Numbers ICMJE | B5061002 GEMINI IF ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
| ||||
IPD Sharing Statement ICMJE |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
| ||||
PRS Account | Pfizer | ||||
Verification Date | November 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |