Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01986660
- Run by
- Strategic Science & Technologies, LLC
- People needed
- 14
- Starts
- 2013-10-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2014-01-27
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- SST Investigational Site — New York, New York, United States
Full record on ClinicalTrials.gov
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