Pharmacokinetics of Transdermal Metronidazole

Inclusion Criteria:

• Men or non-pregnant women ≥18 years old, of any ethnic background

• 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

• Able to adhere to the study protocol schedule, study restrictions and examinationschedule

• Subjects deemed to be healthy, as determined by the study physician, based onmedical history, current medical conditions, and medication history

• Agrees not to participate in another clinical study during the study period unlessthe study is in the follow up phase and it has been 1 month since the subjectreceived any experimental agents or treatments. The subject also agrees not toparticipate in an investigational drug study for at least 1 month after lastprocedure day

• Agrees not to donate blood to a blood bank throughout participation in the study andfor at least 2 months after last procedure day.

Exclusion Criteria:

• Unable to give consent

• Inability to communicate or cooperate with the investigators

• Known previous adverse reaction to microneedle insertion

• Known allergy or adverse reaction to medical tape/adhesive, or aloe vera

• Women who are pregnant or lactating

• Abnormal vital signs or lab values deemed to be medically significant by the studyphysician or Principal Investigator

• Positive urine drug screening test

• Known prior serious adverse reaction or hypersensitivity to metronidazole or anymetronidazole products

• History of anaphylaxis to an antibiotic, antimicrobial, antifungal, antipartisitic,or antiviral drug

• Current smoker or regular use of nicotine or tobacco products

• Participation in any ongoing investigational drug trial or clinical drug trialunless the study is in the follow up phase and it has been ≥1 month since thesubject received any experimental agents or treatments

• Current use of medications in the following therapeutic classes: HMGCoA reductaseinhibitors ("statins"), beta-blockers, oral or topical steroids, oral antibiotics,topical antibiotics at the local treatment site, topical antihistamines at the localtreatment site, and oral or topical NSAIDs/analgesics. A subject who has recentlyused oral or topical steroids, antibiotics, antihistamines, or NSAIDs/analgesics maybe enrolled if more than 5 elimination half-lives of the drug have passed since thelast dose. The estimated elimination half-life for any specific drug will beobtained from standard pharmacy references such as Micromedex or other comparablereferences.

• Current or recent use of any prescription medication that, in the opinion of thestudy physician or Principal Investigator, would present a safety risk when usedconcomitantly with metronidazole

• Any current medical conditions (acute or chronic) that may pose a risk for studyparticipation, as determined by the study physician or Principal Investigator

• Any condition that would, in the opinion of the study physician or PrincipalInvestigator, place the subject at an unacceptable risk of injury or render thesubject unable to meet the requirements of the protocol

• Uncontrolled mental illness that would, in the opinion of the study physician orPrincipal Investigator, affect the subject's ability to understand or reliablyparticipate in the study

• Subject has presence of a skin condition, excessive hair at the application site,sunburn, raised moles and scars, open sores at application site, scar tissue,tattoo, coloration, or any other local condition that would interfere with placementof patches, microneedles, study drug, skin assessment, or reactions to drug

• Medical history of significant dermatologic diseases or conditions, such as atopy,psoriasis, vitiligo or conditions known to alter skin appearance or physiologicresponse (e.g. diabetes, porphyria).

• Any current malignancy or history of malignancy at the treatment site

• Prior history of keloids or excessive scarring

• Prior history of skin pigmentation changes or significant dermal reaction to atopically applied drug product