PK and DPK of Lidocaine Dermal Products

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-14

Study Completion Date

2020-05-15

Brief Summary

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This is a bioequivalence study to compare lidocaine release between a brand name and generic skin patches in healthy adults.

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Detailed Description

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This research study is intended to determine the effect of heat on lidocaine patches. This study will use lidocaine patches (brand name and generic patches) that have been approved by the Food and Drug Administration (FDA) and are already sold to customers in the United States, and will not include any placebos.

Conditions

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Heat Effect

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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name brand patch

name brand lidocaine patch

Group Type OTHER

Lidocaine patch

Intervention Type DRUG

lidocaine patch

generic patch

generic lidocaine patch

Group Type OTHER

Lidocaine patch

Intervention Type DRUG

lidocaine patch

name brand patch-early

name brand lidocaine patch-early

Group Type OTHER

Lidocaine patch

Intervention Type DRUG

lidocaine patch

name brand patch-late

name brand lidocaine patch-late

Group Type OTHER

Lidocaine patch

Intervention Type DRUG

lidocaine patch

generic patch-early

generic lidocaine patch-early

Group Type OTHER

Lidocaine patch

Intervention Type DRUG

lidocaine patch

generic patch-late

generic lidocaine patch-late

Group Type OTHER

Lidocaine patch

Intervention Type DRUG

lidocaine patch

both patches

brand name and generic lidocaine patch

Group Type OTHER

Lidocaine patch

Intervention Type DRUG

lidocaine patch

Interventions

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Lidocaine patch

lidocaine patch

Intervention Type DRUG

Other Intervention Names

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skin patch

Eligibility Criteria

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Inclusion Criteria

1. Men or non-pregnant, women who are of any ethnic background between the age of 18 and 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. Agrees not to participate in another clinical trial/study 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 restrictions and protocol schedule.
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 formulations 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 (minimum 28 cm (11 inch) circumference) large enough to allow for the placement of two 140 cm2 patches on one upper arm or one 140 cm2 patch on each upper arm.
9. Subjects deemed to be healthy as judged by the MAI and determined by medical history, physical examination and medication history.
10. Negative urine drug screening test.
11. Have normal screening laboratories for WBC, CBC, Hgb, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT and 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 procedure day, 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 at least 3 months after the last procedure day.
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 90-140 mmHg
* Diastolic blood pressure 60-90 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 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, patches or electronic cigarettes).
3. Participation in any ongoing investigational drug trial/study or clinical drug trial/study.
4. History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression.
5. Active positive Hepatitis B, C and/or HIV serologies (see Appendix B).
6. Known anemia.
7. Positive urine drug screening test.
8. Use of chronic prescription medication during the period 0 to 30 days; or over-the counter medication (e.g. antihistamines or topical corticosteroids) and short term (\<30 days) prescription medications during the period 0 to 3 days before a study session (vitamin, herbal supplements and birth control medications not included).
9. Donation or loss of greater than one pint of blood within 60 days of entry to the study.
10. Any prior adverse reaction to lidocaine. Hypersensitivity to lidocaine, known history of hypersensitivity to local anesthetics of the amide type, other excipients in the patches tested or to adhesives on tapes used to cover or tape strip treatment sites.
11. 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.
12. 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.
13. Consumption of alcohol within 24 h prior to dose administration.
14. History as either reported by the subject or evident to the investigator of infectious disease or skin infection or of chronic skin disease (e.g., diabetes, psoriasis, atopic dermatitis).
15. Hereditary skin disorders or any skin inflammatory conditions as reported by the research participant or evident to the MAI.
16. History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and did not involve the investigative sites.
17. Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at application site (volar forearms/upper arms), sunburn, raised moles and scars, open sores at application site (volar forearms/upper arms), scar tissue, tattoo or coloration that would interfere with placement of formulations, skin assessment or reactions to lidocaine.
18. BMI ≥30 kg/m2.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes