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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986660
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : January 27, 2014
Sponsor:
Information provided by (Responsible Party):
Strategic Science & Technologies, LLC

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ibuprofen Cream (SST-0225) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : October 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ibuprofen Cream (SST-0225) Drug: Ibuprofen Cream (SST-0225)



Primary Outcome Measures :
  1. Cmax, Tmax, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2 [ Time Frame: 9 days ]

Secondary Outcome Measures :
  1. Clinical laboratory change from baseline [ Time Frame: 14 days ]
  2. Modified Berger Bowman Skin Assessment [ Time Frame: 14 days ]
  3. Vital Signs [ Time Frame: 14 days ]
  4. Adverse Events [ Time Frame: 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986660


Locations
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United States, New York
SST Investigational Site
New York, New York, United States
Sponsors and Collaborators
Strategic Science & Technologies, LLC
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Responsible Party: Strategic Science & Technologies, LLC
ClinicalTrials.gov Identifier: NCT01986660    
Other Study ID Numbers: SST0225-US-011-001
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: January 2014
Keywords provided by Strategic Science & Technologies, LLC:
Pharmacokinetic Study
Additional relevant MeSH terms:
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Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action