Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
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.
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The purpose of this study is to evaluate how Ibuprofen Cream (SST-0225) is absorbed and eliminated by the body under defined maximum dosing conditions and to evaluate the safety under these conditions.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Signed consent form
Men, women, 18 to 55 years
Females must not be pregnant or plan to become pregnant
BMI 18 to 30 kg/m2
Past or non-smoker
High probability of compliance with completion of study
Healthy as determined by investigator based on medical history, physical exam, clinical laboratory tests, vital sign measurements, ECGs
Presence or history of disorder that could interfere with completion of study
Unstable medical condition
Surgical or medical condition that may interfere with absorption, distribution, metabolism or excretion of test drug
Positive Hep B, Hep C and/or HIV test
Positive urine drug screen
Any history of skin disorders, including psoriasis, eczema, tattoos, significant scarring, healing wounds, skin lesions on knees or elbows
Any clinically important deviation from normal limits in physical exam, vital sign measurements, 12 lead ECG, clinical laboratory test
History of drug abuse with 1 year
History of alcoholism with 1 year
Use of prescription medications or ibuprofen within 30 days of Day 1, use of OTC drugs, herbal supplements and vitamins within 14 days of Day 1.
Use of investigational drug within 30 day of Day 1
Acute disease state within 7 days of Day 1
Consumption of grapefruit or grapefruit containing products within 72 hours of Day 1