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

January 23, 2014 updated by: Strategic Science & Technologies, LLC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States
        • SST Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibuprofen Cream (SST-0225)
Drug: Ibuprofen Cream (SST-0225)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Strategic Science & Technologies, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 27, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SST0225-US-011-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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