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

Strategic Science & Technologies

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ibuprofen Cream (SST-0225)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986660

SST0225-US-011-001

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

14 participants in 1 patient group

Ibuprofen Cream (SST-0225)

Experimental group

Treatment:

Drug: Ibuprofen Cream (SST-0225)