Overview
Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
Status:
Completed
Completed
Trial end date:
2013-10-01
2013-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Strategic Science & Technologies, LLCTreatments:
Ibuprofen
Criteria
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