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Evaluation of Bioavailability of Diclofenac Dermal Products

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ClinicalTrials.gov Identifier: NCT03145259
Recruitment Status : Active, not recruiting
First Posted : May 9, 2017
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Audra Stinchcomb, University of Maryland, Baltimore

Brief Summary:
The study will utilize already FDA-approved marketed diclofenac products in healthy adults to generate data for establishing rate of drug delivery comparisons between diclofenac epolamine patches and diclofenac sodium solution in healthy adults and to determine skin concentrations.

Condition or disease Intervention/treatment Phase
Bioavailability Drug: Diclofenac Epolamine Patch Drug: diclofenac sodium solution Early Phase 1

Detailed Description:
The study will utilize already FDA-approved marketed diclofenac products in healthy adults to generate data for establishing rate of drug delivery comparisons between diclofenac epolamine patches and diclofenac sodium solution in healthy adults and to determine skin concentrations. This study supports FDA's continuing effort to identify the most accurate, sensitive, reproducible and efficient methods to evaluate topical dermatological drug products.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Bioavailability of Diclofenac Dermal Products
Actual Study Start Date : April 19, 2017
Actual Primary Completion Date : August 29, 2019
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
diclofenac epolamine patches
diclofenac epolamine patches
Drug: Diclofenac Epolamine Patch
patch
Other Name: patch

diclofenac sodium solution
diclofenac sodium solution
Drug: diclofenac sodium solution
solution
Other Name: solution

diclofenac epolamine patches and diclofenac sodium solution
patch pieces and solution
Drug: Diclofenac Epolamine Patch
patch
Other Name: patch

Drug: diclofenac sodium solution
solution
Other Name: solution




Primary Outcome Measures :
  1. pharmacokinetic [ Time Frame: blood samples obtained over 51 hour time period for study session 1 and over 47 hour time period for study session 2; through study completion ]
    serum diclofenac concentrations

  2. tape stripping of skin [ Time Frame: tape strips of skin obtained at specific time points over a 51 hour time period for study session 3; through study completion ]
    skin diclofenac concentrations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men or non-pregnant, women who are of any ethnic background between the age of 18 to 45 years old
  2. Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products
  3. Provide written informed consent before initiation of any of the study procedures
  4. Agree not to participate in another clinical trial/study during the study period or to participate in an investigational drug study for at least 1 month after the last study session
  5. Able to adhere to the study protocol and study restrictions
  6. Able to participate in all study sessions
  7. Has a volar forearm of either at least 24 cm (9.45 inches) in length or of sufficient size that can accommodate the products to be tested in a study area that begins at least 5 cm (1.97 inches) above the wrist and ends a minimum of 0.5 cm (0.197 inches) below the antecubital fossa (i.e., the bend in the arm at the elbow).
  8. Subjects have upper arms large enough to allow for placement of two 140 cm2 [21.7 in2] patches (distance from acromion process of the scapula to olecranon process should be a minimum of 35 cm [13.8 inches]; circumference of upper arms should be a minimum of 30 cm [11.8 inches] and 200 cm2 [31 in2] area for application of solution
  9. Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination and medication history
  10. Negative urine drug screening test (cannabinoids, amphetamines, barbiturates, benzodiazepine, cocaine, methadone, opiates, PCP)
  11. Have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine transaminase (ALT) and aspartate aminotransferase (AST)
  12. Have normal screening laboratories for urine protein and urine glucose
  13. Female subjects must be of non-childbearing potential (as defined as surgically sterile [i.e. history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of each study session, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner
  14. Agrees not to donate blood to a blood bank throughout participation in the study and for at least 3 months after last study session
  15. Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block. (sinus rhythm is between 55-100 beats per minute)
  16. Have normal vital signs:

    • Temperature 35-37.9°C (95-100.3°F)
    • Systolic blood pressure 90-165 mmHg
    • Diastolic blood pressure 60-100 mmHg
    • Heart rate 55-100 beats per minute
    • Respiration rate 12-20 breaths per minute

Exclusion Criteria:

  1. Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of the first day of each study session
  2. Smokers (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patch or electronic cigarettes)
  3. Participation in any ongoing investigational drug trial/study or clinical drug trial/study
  4. History as either reported by the subject or evident to the Medically Accountable Investigator (MAI) of infectious disease or skin infection or of chronic skin disease (e.g., psoriasis, atopic dermatitis)
  5. History of diabetes
  6. History of significant skin cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and did not involve the investigative sites
  7. Body Mass Index (BMI) ≥30 kg/m2
  8. History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression
  9. Active positive Hepatitis B, C and/or HIV serologies
  10. Positive urine drug screening test
  11. Use of any prescription medication during the period 0 to 30 days or over-the-counter medication e.g. antihistamines, topical corticosteroids during the period 0-5 days before entry to the study (vitamins, herbal supplements and birth control medications not included)
  12. Currently taking daily oral nonsteroidal anti-inflammatory drug [NSAIDs] (aspirin, ibuprofen, naproxen, etc…)
  13. Currently taking daily anticoagulants or within the past month prior to entry into the study (warfarin, heparin, rivaroxaban, dabigatran, etc…), ACE-inhibitors, cyclosporine, diuretics, lithium or methotrexate
  14. Donation or loss of greater than one pint of blood within 60 days of entry to the study
  15. Any prior adverse reaction or hypersensitivity to diclofenac, aspirin, ibuprofen, naproxen or other nonsteroidal anti-inflammatory drug (NSAID), other inactive ingredients in the patch or topical solution or to adhesives or tapes used to cover or tape strip the treatment sites
  16. Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month before enrollment in this study or expects to receive an experimental agent during the study
  17. Eat or drink anything containing alcohol within 24 hours prior to dose administration
  18. Any condition that would, in the opinion of the Medically Accountable Investigator (MAI), place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
  19. Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at the application site (upper arms/volar forearms), sunburn, raised moles or scars, open sores at application site (upper arms/volar forearms), scar tissue, tattoo, or coloration that would interfere with placement of diclofenac products, skin assessment, or reactions to diclofenac
  20. History of asthma or urticaria,, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease
  21. History of gastrointestinal bleeding or peptic ulcer disease

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): NCT03145259


Locations
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United States, Maryland
General Clinical Research Center (GCRC) at the University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Food and Drug Administration (FDA)
Investigators
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Principal Investigator: Audra L Stinchcomb, PhD University of Maryland Baltimore School of Pharmacy
Principal Investigator: Hazem E Hassan, PhD University of Maryland Baltimore School of Pharmacy

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Responsible Party: Audra Stinchcomb, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03145259     History of Changes
Other Study ID Numbers: HP-00067047
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diclofenac
Diclofenac hydroxyethylpyrrolidine
Pharmaceutical Solutions
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