Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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

 -  Significant disease

 -  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

 -  Tobacco use/caffeine use within 48 hours of Day 1