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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: 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 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Strategic Science & Technologies, LLC
• Treatments: 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