Pharmacokinetics of Lidocaine in Healthy Adults

Inclusion Criteria

• Men or non-pregnant women, of any ethnic background, between the age of 18 and 65 years old.
• Provide written informed consent before initiation of any study procedures.
• Available for follow-up for the planned duration of the study.
• Able to communicate well with the investigators.
• 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.
• Able to adhere to the study protocol schedule, study restrictions and examination schedule.
• 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.
• Subjects who are within their ideal body weight (BMI between 18-29.9 kg/m2).
• Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI), as determined by medical history, physical examination, and medication history.
• Negative urine drug screening test.
• Have a normal blood pressure (systolic: 90-139 mmHg; diastolic: 60-89 mmHg) and heart rate (55-100 bpm).
• Have normal screening laboratories for WBC, Hgb, Hct, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT, AST.
• 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.
• 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.
• Agrees not to donate blood to a blood bank throughout participation in the study and for at least 60 days after last procedure day.
• 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

• 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.
• 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.
• Participation in any ongoing investigational drug trial or clinical drug trial pe