HealthyPhase 4NCT05929794
Pharmacokinetics of Transdermal Metronidazole
A Phase 4 study testing Metronidazole 0.75% Topical Gel, Metronidazole 0.75% Topical Cream and Transdermal water loss measurement in people with Healthy, run by University of Iowa at 1 site in United States.
Trial summary
This is a crossover pharmacokinetic clinical study in healthy volunteers to compare metronidazole delivery through skin when a gel or cream metronidazole product is applied to skin treated with a micropatch. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Metronidazole 0.75% Topical Gel, Metronidazole 0.75% Topical Cream and Transdermal water loss measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 examination schedule
- Subjects deemed to be healthy, as determined by the study physician, based on medical history, current medical conditions, and medication history
- 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 1 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 1 month after last procedure day
- Agrees not to donate blood to a blood bank throughout participation in the study and for at least 2 months after last procedure day.
Who cannot join
- 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 study physician or Principal Investigator
Show all 21Show fewer
- Positive urine drug screening test
- Known prior serious adverse reaction or hypersensitivity to metronidazole or any metronidazole 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 trial unless the study is in the follow up phase and it has been ≥1 month since the subject received any experimental agents or treatments
- Current use of medications in the following therapeutic classes: HMGCoA reductase inhibitors ("statins"), beta-blockers, oral or topical steroids, oral antibiotics, topical antibiotics at the local treatment site, topical antihistamines at the local treatment site, and oral or topical NSAIDs/analgesics. A subject who has recently used oral or topical steroids, antibiotics, antihistamines, or NSAIDs/analgesics may be enrolled if more than 5 elimination half-lives of the drug have passed since the last dose. The estimated elimination half-life for any specific drug will be obtained from standard pharmacy references such as Micromedex or other comparable references.
- Current or recent use of any prescription medication that, in the opinion of the study physician or Principal Investigator, would present a safety risk when used concomitantly with metronidazole
- Any current medical conditions (acute or chronic) that may pose a risk for study participation, as determined by the study physician or Principal Investigator
- Any condition that would, in the opinion of the study physician or Principal Investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
- Uncontrolled mental illness that would, in the opinion of the study physician or Principal Investigator, affect the subject's ability to understand or reliably participate 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 placement of 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 physiologic response (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 a topically applied drug product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Formulation on the Pharmacokinetics of Micropatch-assisted Delivery of Metronidazole
This is a crossover pharmacokinetic clinical study in healthy volunteers to compare metronidazole delivery through skin when a gel or cream metronidazole product is applied to skin treated with a micropatch.
Read the detailed description
The goal of this crossover pharmacokinetic clinical study in healthy volunteers is to compare metronidazole delivery through skin when a gel or cream metronidazole product is applied to skin treated with a micropatch. The main questions this study aims to answer are:
- Is micropatch transdermal delivery dependent on the metronidazole product formulation?
- Is transdermal delivery dependent on micropore lifetime of the skin after micropatch application?
Participants will be divided into groups based on metronidazole product (gel or cream).
- The metronidazole product will be applied to micropatch-treated skin in study period one. Measurements of the skin barrier will be made before and after micropatch treatment.
- Daily blood samples will be collected for up to 5 days after the micropatch and metronidazole are first applied.
- Following a one-week washout period, the same study process will be repeated except that metronidazole product will be applied to skin without micropatch pretreatment.
- Conditions
- Healthy
- Being tested
- Metronidazole 0.75% Topical Gel, Metronidazole 0.75% Topical Cream, Transdermal water loss measurement, Electrical Resistance, Skin color measurement
- Keywords
- Microneedle, Micropatch, Transdermal, Metronidazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole 0.75% Topical GelDrug
Half of enrolled subjects will undergo this intervention. Baseline measurements of transepidermal water loss, electrical resistance, and color will be made at 3 sites on the upper arm. Color will only be measured at baseline. Micropatch application will occur at 2 sites, followed by application of metronidazole gel and then covered with an occlusive covering. One site will be covered with an occlusive covering only (no micropatch or gel). At 48 hours occlusive coverings and gel are removed and electrical resistance measurements are repeated. Fresh gel and occlusive patches are reapplied. At 96 hours the patches are removed and electrical resistance measurements repeated. Blood samples are taken daily for 5 days. Measurements from the 3rd site allow each subject to serve as their own control in data analysis. After a minimum 7 days washout period, all of these procedures will be repeated again except that there will be no micropatch application at any of the 3 sites.
Metronidazole 0.75% Topical CreamDrug
Half of enrolled subjects will undergo this intervention. Baseline measurements of transepidermal water loss, electrical resistance, and color will be made at 3 sites on the upper arm. Color will only be measured at baseline. Micropatch application will occur at 2 sites, followed by application of metronidazole cream and then covered with an occlusive covering. One site will be covered with an occlusive covering only (no micropatch or cream). At 48 hours occlusive coverings and cream are removed and electrical resistance measurements are repeated. Fresh cream and occlusive patches are reapplied. At 96 hours the patches are removed and electrical resistance measurements repeated. Blood samples are taken daily for 5 days. Measurements from the 3rd site allow each subject to serve as their own control in data analysis. After a minimum 7 days washout period, all of these procedures will be repeated again except that there will be no micropatch application at any of the 3 sites.
Transdermal water loss measurementDiagnostic test
Baseline measurements of transepidermal water loss will be made at 3 sites on the upper arm. In the study periods that have micropatch application, the measurements will be repeated after micropatch application and removal (before any metronidazole product is applied).
Electrical ResistanceDiagnostic test
Baseline measurements of electrical resistance will be made at 3 sites on the upper arm. In the study periods that have micropatch application, the measurements will be repeated after micropatch application and removal (before any metronidazole product is applied). In all study periods the measurements will also be repeated at 48 hours and 96 hours, when metronidazole product and occlusive coverings are removed from the skin.
Skin color measurementDiagnostic test
Baseline measurements of skin color will be made at 3 sites on the upper arm.
Micropatch applicationOther
All subjects will undergo this intervention. Baseline measurements of transepidermal water loss, electrical resistance, and color will be made at 3 sites on the upper arm (color only measured at baseline). Two sites will have micropatch application + metronidazole product with occlusive covering. One site will have micropatch application + occlusive covering, no metronidazole product. Micropatch application will only occur on day 1 (a micropatch is a patch of 50 microneedles). Transepidermal water loss and electrical resistance are repeated after micropatch application and removal. At 48 hours occlusive coverings and metronidazole are removed; electrical resistance measurements are repeated. Metronidazole product and fresh occlusive patches are reapplied. At 96 hours patches are removed and electrical resistance measurements repeated. Blood samples are taken daily for 5 days. Measurements from the 3rd site allow each subject to serve as their own control in data analysis.
| Study group | Role | What they receive |
|---|---|---|
| Micropatch application + metronidazole 0.75% topical gel | Active comparator | Participants will have pre-treatment micropatch application followed by metronidazole 0.75% topical gel Receives: Drug: Metronidazole 0.75% Topical Gel; Diagnostic Test: Transdermal water loss measurement; Diagnostic Test: Electrical Resistance; Diagnostic Test: Skin color measurement; Other: Micropatch application |
| Metronidazole 0.75% topical gel | Active comparator | Participants will have metronidazole 0.75% topical gel applied without the pre-treatment micropatch application Receives: Drug: Metronidazole 0.75% Topical Gel; Diagnostic Test: Transdermal water loss measurement; Diagnostic Test: Electrical Resistance; Diagnostic Test: Skin color measurement |
| Micropatch application + metronidazole 0.75% topical cream | Active comparator | Participants will have pre-treatment micropatch application followed by metronidazole 0.75% topical cream Receives: Drug: Metronidazole 0.75% Topical Cream; Diagnostic Test: Transdermal water loss measurement; Diagnostic Test: Electrical Resistance; Diagnostic Test: Skin color measurement; Other: Micropatch application |
| Metronidazole 0.75% topical cream | Active comparator | Participants will have metronidazole 0.75% topical cream applied without the pre-treatment micropatch application Receives: Drug: Metronidazole 0.75% Topical Cream; Diagnostic Test: Transdermal water loss measurement; Diagnostic Test: Electrical Resistance; Diagnostic Test: Skin color measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of maximum serum metronidazole concentration (Cmax)
Cmax is the highest metronidazole concentration measured in the serum.
Measured: 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 96, 98, 100, 104, and 120 hours
Time of maximum serum metronidazole concentration (Tmax)
Tmax is the time point at which the maximum drug concentration in serum is measured.
Measured: 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 96, 98, 100, 104, and 120 hours
Area under the serum-concentration curve from 0-120 hours
Area under the serum-concentration-time curve is a mathematical measure of total systemic exposure to metronidazole in the body.
Measured: 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 96, 98, 100, 104, and 120 hours
Secondary outcomes (3)
Skin color
Lightness/darkness of the skin is measured with a tristimulus colorimeter and reported in a unitless value called L*. Higher L* values denote lighter skin, while lower L* values denote darker skin. Data are collected as the mean of measurements from 3 sites on the upper arm.
Measured: Baseline (Day 1)
Change in transepidermal water loss after micropatch application
The percent change in transepidermal water loss from baseline to post-micropatch application at the upper arm sites will be calculated. These data are only collected from the micropatch sites. Percent change is calculated as (transepidermal water loss after micropatch application/baseline transepidermal water loss) x 100. Data will be calculated as the mean of measurements from micropatch application sites at the upper arm.
Measured: Baseline (Day 1) and post-micropatch application (Day 1)
Change in electrical resistance after micropatch application
The percent change in electrical resistance from baseline to post-micropatch application at the upper arm sites will be calculated. These data are only collected from the micropatch sites. Percent change is calculated as (electrical resistance after micropatch application/baseline electrical resistance) x 100. Data will be calculated as the mean of measurements from micropatch application sites at the upper arm.
Measured: Baseline (Day 1) and post-micropatch application (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start26 Feb 2024
- Primary completion31 Jul 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is an open-label, 2-way crossover, non-placebo controlled pharmacokinetic assessment study in n=24 health adult subjects. In this crossover study, all subjects will receive treatment with either metronidazole gel or cream, depending on assigned study group. During different periods of the study, the metronidazole product will be applied to skin treated with a micropatch (period 1) and to skin not treated with a micropatch (period 2) on the upper arm.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole K Brogden, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929794
- Sponsor's protocol ID
- 202211064
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Formulation on the Pharmacokinetics of Micropatch-assisted Delivery of Metronidazole
- ClinicalTrials.gov ID
- NCT05929794
- Acronym / sponsor ID
- 202211064
- Conditions
- Healthy
- Keywords
- Microneedle, Micropatch, Transdermal, Metronidazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a crossover pharmacokinetic clinical study in healthy volunteers to compare metronidazole delivery through skin when a gel or cream metronidazole product is applied to skin treated with a micropatch.
Detailed description
The goal of this crossover pharmacokinetic clinical study in healthy volunteers is to compare metronidazole delivery through skin when a gel or cream metronidazole product is applied to skin treated with a micropatch. The main questions this study aims to answer are:
- Is micropatch transdermal delivery dependent on the metronidazole product formulation?
- Is transdermal delivery dependent on micropore lifetime of the skin after micropatch application?
Participants will be divided into groups based on metronidazole product (gel or cream).
- The metronidazole product will be applied to micropatch-treated skin in study period one. Measurements of the skin barrier will be made before and after micropatch treatment.
- Daily blood samples will be collected for up to 5 days after the micropatch and metronidazole are first applied.
- Following a one-week washout period, the same study process will be repeated except that metronidazole product will be applied to skin without micropatch pretreatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is an open-label, 2-way crossover, non-placebo controlled pharmacokinetic assessment study in n=24 health adult subjects. In this crossover study, all subjects will receive treatment with either metronidazole gel or cream, depending on assigned study group. During different periods of the study, the metronidazole product will be applied to skin treated with a micropatch (period 1) and to skin not treated with a micropatch (period 2) on the upper arm.
| Arm | Type | Receives |
|---|---|---|
| Micropatch application + metronidazole 0.75% topical gel | Active comparator | Drug: Metronidazole 0.75% Topical Gel, Diagnostic Test: Transdermal water loss measurement, Diagnostic Test: Electrical Resistance, Diagnostic Test: Skin color measurement, Other: Micropatch applicationParticipants will have pre-treatment micropatch application followed by metronidazole 0.75% topical gel |
| Metronidazole 0.75% topical gel | Active comparator | Drug: Metronidazole 0.75% Topical Gel, Diagnostic Test: Transdermal water loss measurement, Diagnostic Test: Electrical Resistance, Diagnostic Test: Skin color measurementParticipants will have metronidazole 0.75% topical gel applied without the pre-treatment micropatch application |
| Micropatch application + metronidazole 0.75% topical cream | Active comparator | Drug: Metronidazole 0.75% Topical Cream, Diagnostic Test: Transdermal water loss measurement, Diagnostic Test: Electrical Resistance, Diagnostic Test: Skin color measurement, Other: Micropatch applicationParticipants will have pre-treatment micropatch application followed by metronidazole 0.75% topical cream |
| Metronidazole 0.75% topical cream | Active comparator | Drug: Metronidazole 0.75% Topical Cream, Diagnostic Test: Transdermal water loss measurement, Diagnostic Test: Electrical Resistance, Diagnostic Test: Skin color measurementParticipants will have metronidazole 0.75% topical cream applied without the pre-treatment micropatch application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 examination schedule
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metronidazole 0.75% Topical GelHalf of enrolled subjects will undergo this intervention. Baseline measurements of transepidermal water loss, electrical resistance, and color will be made at 3 sites on the upper arm. Color will only be measured at baseline. Micropatch application will occur at 2 sites, followed by application of metronidazole gel and then covered with an occlusive covering. One site will be covered with an occlusive covering only (no micropatch or gel). At 48 hours occlusive coverings and gel are removed and electrical resistance measurements are repeated. Fresh gel and occlusive patches are reapplied. At 96 hours the patches are removed and electrical resistance measurements repeated. Blood samples are taken daily for 5 days. Measurements from the 3rd site allow each subject to serve as their own control in data analysis. After a minimum 7 days washout period, all of these procedures will be repeated again except that there will be no micropatch application at any of the 3 sites. | Drug | Metronidazole 0.75% topical gel, Micropatch application + metronidazole 0.75% topical gel |
| Metronidazole 0.75% Topical CreamHalf of enrolled subjects will undergo this intervention. Baseline measurements of transepidermal water loss, electrical resistance, and color will be made at 3 sites on the upper arm. Color will only be measured at baseline. Micropatch application will occur at 2 sites, followed by application of metronidazole cream and then covered with an occlusive covering. One site will be covered with an occlusive covering only (no micropatch or cream). At 48 hours occlusive coverings and cream are removed and electrical resistance measurements are repeated. Fresh cream and occlusive patches are reapplied. At 96 hours the patches are removed and electrical resistance measurements repeated. Blood samples are taken daily for 5 days. Measurements from the 3rd site allow each subject to serve as their own control in data analysis. After a minimum 7 days washout period, all of these procedures will be repeated again except that there will be no micropatch application at any of the 3 sites. | Drug | Metronidazole 0.75% topical cream, Micropatch application + metronidazole 0.75% topical cream |
| Transdermal water loss measurementBaseline measurements of transepidermal water loss will be made at 3 sites on the upper arm. In the study periods that have micropatch application, the measurements will be repeated after micropatch application and removal (before any metronidazole product is applied). | Diagnostic test | Metronidazole 0.75% topical cream, Metronidazole 0.75% topical gel, Micropatch application + metronidazole 0.75% topical cream, Micropatch application + metronidazole 0.75% topical gel |
| Electrical ResistanceBaseline measurements of electrical resistance will be made at 3 sites on the upper arm. In the study periods that have micropatch application, the measurements will be repeated after micropatch application and removal (before any metronidazole product is applied). In all study periods the measurements will also be repeated at 48 hours and 96 hours, when metronidazole product and occlusive coverings are removed from the skin. | Diagnostic test | Metronidazole 0.75% topical cream, Metronidazole 0.75% topical gel, Micropatch application + metronidazole 0.75% topical cream, Micropatch application + metronidazole 0.75% topical gel |
| Skin color measurementBaseline measurements of skin color will be made at 3 sites on the upper arm. | Diagnostic test | Metronidazole 0.75% topical cream, Metronidazole 0.75% topical gel, Micropatch application + metronidazole 0.75% topical cream, Micropatch application + metronidazole 0.75% topical gel |
| Micropatch applicationAll subjects will undergo this intervention. Baseline measurements of transepidermal water loss, electrical resistance, and color will be made at 3 sites on the upper arm (color only measured at baseline). Two sites will have micropatch application + metronidazole product with occlusive covering. One site will have micropatch application + occlusive covering, no metronidazole product. Micropatch application will only occur on day 1 (a micropatch is a patch of 50 microneedles). Transepidermal water loss and electrical resistance are repeated after micropatch application and removal. At 48 hours occlusive coverings and metronidazole are removed; electrical resistance measurements are repeated. Metronidazole product and fresh occlusive patches are reapplied. At 96 hours patches are removed and electrical resistance measurements repeated. Blood samples are taken daily for 5 days. Measurements from the 3rd site allow each subject to serve as their own control in data analysis. | Other | Micropatch application + metronidazole 0.75% topical cream, Micropatch application + metronidazole 0.75% topical gel |
Primary outcome
Measurement of maximum serum metronidazole concentration (Cmax)
Time frame: 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 96, 98, 100, 104, and 120 hours
Cmax is the highest metronidazole concentration measured in the serum.
Time of maximum serum metronidazole concentration (Tmax)
Time frame: 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 96, 98, 100, 104, and 120 hours
Tmax is the time point at which the maximum drug concentration in serum is measured.
Area under the serum-concentration curve from 0-120 hours
Time frame: 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 96, 98, 100, 104, and 120 hours
Area under the serum-concentration-time curve is a mathematical measure of total systemic exposure to metronidazole in the body.
3 secondary outcomes
Skin color
Time frame: Baseline (Day 1)
Change in transepidermal water loss after micropatch application
Time frame: Baseline (Day 1) and post-micropatch application (Day 1)
Change in electrical resistance after micropatch application
Time frame: Baseline (Day 1) and post-micropatch application (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole 0.75% Topical Gel, Metronidazole 0.75% Topical Cream and Transdermal water loss measurement in people with Healthy, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of maximum serum metronidazole concentration (Cmax) (time frame: 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 96, 98, 100, 104, and 120 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.