Pharmacokinetics of Lidocaine in Healthy Adults (NCT03310970) | Clinical Trial Compass
CompletedPhase 4
Pharmacokinetics of Lidocaine in Healthy Adults
United States23 participantsStarted 2018-03-14
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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).
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.
What they're measuring
1
Measurement of Maximum Serum Concentration of Lidocaine (Cmax)
Timeframe: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
✕. 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.
✕. Abnormal vital signs, defined as:
✕. 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.
✕. History of chronic obstructive pulmonary disease.
✕. Positive urine drug screening test.
✕. 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).