Pharmacokinetics of Lidocaine in Healthy Adults
Condition: Healthy
Intervention: Lidocaine 5% patch; Lidocaine hydrochloride; Lidoderm 5% patch
Intervention description: Each subject will wear three generic Lidocaine 5% topical patches for 12 hours.; Each subject will receive a dose of 0.5 mg/kg intravenously over a period of 5 minutes.; Each subject will wear three Lidoderm® topical patches for 12 hours.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Peer Reviewed Research

Summary:

      The study to be performed will utilize already FDA-approved marketed products in healthy
      adults for the purpose to generate data for establishing rate of drug delivery of Lidoderm®
      topical patch (manufactured by Endo Pharmaceuticals) and the lidocaine 5% patch (manufactured
      by Mylan Pharmaceuticals) in healthy adults, and to ensure the safety of individuals
      utilizing these types of products.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or non-pregnant women, of any ethnic background, between the age of 18 and 65
             years old.

          2. Provide written informed consent before initiation of any study procedures.

          3. Available for follow-up for the planned duration of the study.

          4. Able to communicate well with the investigators.

          5. Demonstrate comprehension of the protocol procedures and knowledge of study, as
             demonstrated by a study member filling out a consent checklist form to verify that the
             subject understands all aspects of the study including the purpose, procedures, risks
             and benefits.

          6. Able to adhere to the study protocol schedule, study restrictions and examination
             schedule.

          7. Subjects must be non-smokers and not regular users of tobacco. They must have
             refrained from regular and habitual use of nicotine-containing substances, including
             tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic
             cigarettes) over the previous 12 months and must have not used any nicotine-containing
             products in the previous 30 days.

          8. Subjects who are within their ideal body weight (BMI between 18-29.9 kg/m2).

          9. Subjects deemed to be healthy as judged by the Medically Accountable Investigator
             (MAI), as determined by medical history, physical examination, and medication history.

         10. Negative urine drug screening test.

         11. Have a normal blood pressure (systolic: 90-139 mmHg; diastolic: 60-89 mmHg) and heart
             rate (55-100 bpm).

         12. Have normal screening laboratories for WBC, Hgb, Hct, platelets, sodium, potassium,
             chloride, bicarbonate, BUN, creatinine, ALT, AST.

         13. Female subjects must be of non-childbearing potential. This is defined as surgically
             sterile (i.e. history of hysterectomy or tubal ligation), or postmenopausal for more
             than 1 year (no bleeding for 12 consecutive months). If the person is of childbearing
             potential they must be non-pregnant at the time of enrollment and on the morning of
             the first day of each study treatment procedure day (a urine pregnancy test will be
             administered if it has been >30 days since serum pregnancy test for enrollment). The
             person must also 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 participate in another clinical study during the study period unless the
             study is in the follow-up phase and it has been one month since the subject received
             any experimental agents or treatments. The subject also agrees not to participate in
             an investigational drug study for at least 30 days after last procedure day.

         15. Agrees not to donate blood to a blood bank throughout participation in the study and
             for at least 60 days after last procedure day.

         16. Have a normal ECG; must not have any of the following: pathologic Q wave
             abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right
             bundle branch block, left bundle branch block, advanced A-V heart block, non-sinus
             rhythm, excluding isolated premature atrial contractions (sinus rhythm is not between
             55-100 beats per minute), or any other abnormality that, in the opinion of the MAI,
             makes it unsafe for the subject to participate in the study.

        Exclusion Criteria:

          1. Women who are pregnant or lactating or have a positive serum pregnancy test at
             enrollment or positive urine pregnancy test at any time during the study.

          2. Smokers. A "smoker", for the purposes of the study, will be defined as an individual
             who has regularly and habitually used nicotine-containing substances, including
             tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic
             cigarettes) over the past 12 months. Occasional recreational use (less than once
             monthly) will not warrant exclusion unless the individual has used nicotine-containing
             substances in the previous 30 days before study enrollment.

          3. Participation in any ongoing investigational drug trial or clinical drug trial period
             unless the study is in the follow-up phase and it has been ≥ one month since the
             subject received any experimental agents or treatments.

          4. Abnormal vital signs, defined as:

               -  Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90
                  mmHg) at rest on two separate days.

               -  Heart rate <55 at rest on two separate days

               -  Respiratory rate ≤ 11 to ≥ 18 breaths per minute

          5. Temperature >38.0ºC (100.4ºF) or symptoms of an acute self-limited illness such as an
             upper respiratory infection or gastroenteritis within seven days of administration of
             a study product.

          6. History of chronic obstructive pulmonary disease.

          7. Positive urine drug screening test.

          8. Use of any prescription medication during the period 0 to 30 days or over-the counter
             medication during the period 0 to 3 days before entry to the study (vitamins, herbal
             supplements and birth control medications will be allowed).

          9. Use of medications or treatments that would significantly influence or exaggerate
             responses to the test product or that would alter inflammatory or immune response to
             the product. This includes antihistamines (within 72 hours prior to dosing), systemic
             or topical corticosteroids within four weeks prior to dosing, use of monoamine oxidase
             inhibitors 21 days prior to study, cyclosporine, tacrolimus, cytotoxic drugs, immune
             globulin, Bacillus Calmette-Guerin [BCG], monoclonal antibodies, or radiation therapy.

         10. Donation or loss of greater than one pint of blood within 60 days of entry to the
             study.

         11. Any prior serious adverse reaction or hypersensitivity to lidocaine administered by
             any route.

         12. Current diagnosis of any major psychiatric illness.

         13. Received an experimental agent (vaccine, drug, biologic, device, blood product or
             medication) within 30 days before enrollment in this study or expects to receive an
             experimental agent during the study.

         14. Medical history of a serious chronic condition, including (but not limited to):
             allergic conditions such as anaphylaxis to food or drugs; asthma; generalized drug
             reactions; any seizure disorder; any central nervous system disorder; glaucoma (open
             or closed angle); history of pyloric or urinary bladder neck obstruction; intestinal
             obstruction; difficulty swallowing; stomach or bowel problems (e.g, blockage, muscle
             weakness, ulcerative colitis, Crohn's disease); bleeding disorders; acid reflux
             disease; myasthenia gravis; allergy to belladonna alkaloids; impaired hepatic or renal
             function.

         15. Any condition that would, in the opinion of the Principal Investigator (PI) or MAI,
             place the subject at an unacceptable risk of injury or render the subject unable to
             meet the requirements of the protocol.

         16. Inability to communicate or cooperate with the investigators.

         17. Medical history of significant dermatologic diseases or conditions, such as atopy,
             psoriasis, vitiligo or conditions known to alter skin appearance or physiologic
             response (e.g. diabetes, porphyria).

         18. History of significant dermatologic cancers (e.g. melanoma, squamous cell carcinoma),
             except basal cell carcinomas that were superficial and did not involve the
             investigative site.

         19. History of consumption of alcohol within 24 hours prior to dose administration.

         20. Subject has an obvious difference in skin color at patch sites (compared to
             neighboring skin), or the presence of a skin condition, excessive hair at the
             application site, sunburn, raised moles and scars, open sores at application site,
             scar tissue, tattoo, or coloration that would interfere with placement of test
             articles, or the assessment of the skin and/or reactions to drug.