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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01986660

Enrollment

Registered

2013-11-18

Start date

2013-10-31

Completion date

2013-10-31

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetic Study

Brief 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.

Interventions

DRUGIbuprofen Cream (SST-0225)

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cmax, Tmax, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2	9 days

Secondary

Measure	Time frame
Clinical laboratory change from baseline	14 days
Modified Berger Bowman Skin Assessment	14 days
Vital Signs	14 days
Adverse Events	14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026