BioequivalenceEarly Phase 1NCT03271983
Pharmacokinetics of Metronidazole Dermal Products
A Early Phase 1 study testing Metronidazole gel 1, Metronidazole gel 2 and Metronidazole cream in people with Bioequivalence, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Generate human PK data by collecting data following the application of metronidazole formulations. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Metronidazole gel 1, Metronidazole gel 2 and Metronidazole cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 3 Nov 2019
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or non-pregnant, women who are of any ethnic background between the age of 18 to 45 years old
- Subjects must be non-smokers/tobacco users (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
- Provide written informed consent before initiation of any of the study procedures
- Agree not to participate in another clinical trial/study during the study period or to participate in an investigational drug study for at least 1 month after the last study session
- Able to adhere to the study protocol and study restrictions
- Able to participate in all study sessions
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- Subjects have upper arms large enough to allow for placement of 200 cm2 [31 in2] area for applications of gel or cream. The arm distance from the greater tubercle to the olecranon process should be a minimum of 30 cm. The circumference of the upper arms should be a minimum of 30 cm.
- Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination and medication history
- Negative urine drug screening test (cannabinoids, amphetamines, barbiturates, benzodiazepine, cocaine, methadone, opiates, PCP)
- Have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine transaminase (ALT) and aspartate aminotransferase (AST)
- Have normal screening laboratories for urine protein and urine glucose
- 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 study session, and must agree to use reliable 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 donate blood to a blood bank throughout participation in the study and for at least 3 months after last study session
- 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)
- Have normal vital signs:
- Temperature 35-37.9°C (95-100.3°F)
- Systolic blood pressure 90-165 mmHg
- Diastolic blood pressure 60-100 mmHg
- Heart rate 55-100 beats per minute
- Respiration rate 12-20 breaths per minute
Who cannot join
- 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 the first day of any study session
- Smokers/tobacco users (current use or use over the previous 2 months of nicotine-containing substances (e.g., cigarettes, cigars, chewing tobacco, gum, snuff, patch or electronic cigarettes)
- Current participation in any ongoing investigational drug trial/study or clinical drug trial/study
- 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., psoriasis, atopic dermatitis)
- History of diabetes
- History of significant skin cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and did not involve the investigative sites
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- Body Mass Index (BMI) ≥30 kg/m2
- History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression
- Active positive Hepatitis B, C and/or HIV test results
- Positive urine drug screening test
- Use of chronic prescription medications during the period 0 to 30 days; or over-the-counter medications (e.g. antihistamines, topical corticosteroids) and short term (<30 days) prescription medications during the period 0-3 days before a study session (vitamins, herbal supplements and birth control medications not included)
- Currently taking daily anticoagulants (warfarin, heparin, rivaroxaban, dabigatran, etc…) within the past month prior to entry into the study
- History of blood dyscrasia (abnormal in structure, function and quality)
- History of Crohn's disease
- Donation or loss of greater than one pint of blood within 60 days of entry to the study
- Any prior adverse reaction or hypersensitivity to metronidazole, parabens, other inactive ingredients in the topical gel or cream formulations
- 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
- Consumption (food or drink) of alcohol within 48 h prior to dose administration
- 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
- Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at the application site (upper arms), sunburn, raised moles or scars, open sores at application site (upper arms), scar tissue, tattoo, or coloration that would interfere with placement of metronidazole products, skin assessment, or reactions to metronidazole
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center (GCRC) at the University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Evaluation of the Bioavailability of Metronidazole Dermal Products
Generate human PK data by collecting data following the application of metronidazole formulations.
Read the detailed description
This research study is intended to develop models for in vitro/in vivo correlation (IVIVC) of drug absorption from dermal products. This study will use metronidazole products that have already been approved by the Food and Drug Administration (FDA) and are already sold to customers in the United States; will not include any placebos.
- Conditions
- Bioequivalence
- Being tested
- Metronidazole gel 1, Metronidazole gel 2, Metronidazole cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole gel 1Drug
Also called metronidazole
RLD gel
Metronidazole gel 2Drug
Also called metronidazole
generic gel
Metronidazole creamDrug
Also called metronidazole
generic cream
| Study group | Role | What they receive |
|---|---|---|
| metronidazole gel 1 | Other | RLD gel Receives: Drug: Metronidazole gel 1 |
| metronidazole gel 2 | Other | generic gel Receives: Drug: Metronidazole gel 2 |
| metronidazole cream | Other | generic cream Receives: Drug: Metronidazole cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Parameters
Area under the concentration-time curve from 0 to 25 h
Measured: 3 study sessions/subject; each session was 25 h; blood samples obtained at the following time points: -60 min, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 23, 24, 25 h; at least one week washout period between each study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start9 Apr 2019
- Primary completion31 Oct 2019
- Study completion3 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Audra Stinchcomb, University of Maryland, Baltimore
- Investigators
- Audra L Stinchcomb, PhD, Principal investigator, University of Maryland, Baltimore School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271983
- Sponsor's protocol ID
- HP-00071790
- Status last verified
- Mar 2022
- First submitted
- 29 Aug 2017
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Bioavailability of Metronidazole Dermal Products
- ClinicalTrials.gov ID
- NCT03271983
- Acronym / sponsor ID
- HP-00071790
- Conditions
- Bioequivalence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 3 Nov 2019 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Generate human PK data by collecting data following the application of metronidazole formulations.
Detailed description
This research study is intended to develop models for in vitro/in vivo correlation (IVIVC) of drug absorption from dermal products. This study will use metronidazole products that have already been approved by the Food and Drug Administration (FDA) and are already sold to customers in the United States; will not include any placebos.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| metronidazole gel 1 | Other | Drug: Metronidazole gel 1RLD gel |
| metronidazole gel 2 | Other | Drug: Metronidazole gel 2generic gel |
| metronidazole cream | Other | Drug: Metronidazole creamgeneric cream |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Men or non-pregnant, women who are of any ethnic background between the age of 18 to 45 years old
- Subjects must be non-smokers/tobacco users (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
- Provide written informed consent before initiation of any of the study procedures
- Agree not to participate in another clinical trial/study during the study period or to participate in an investigational drug study for at least 1 month after the last study session
- Able to adhere to the study protocol and study restrictions
Key exclusion criteria (20 listed)
- 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 the first day of any study session
- Smokers/tobacco users (current use or use over the previous 2 months of nicotine-containing substances (e.g., cigarettes, cigars, chewing tobacco, gum, snuff, patch or electronic cigarettes)
- Current participation in any ongoing investigational drug trial/study or clinical drug trial/study
- 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., psoriasis, atopic dermatitis)
- History of diabetes
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 gel 1Also: metronidazoleRLD gel | Drug | metronidazole gel 1 |
| Metronidazole gel 2Also: metronidazolegeneric gel | Drug | metronidazole gel 2 |
| Metronidazole creamAlso: metronidazolegeneric cream | Drug | metronidazole cream |
Primary outcome
PK Parameters
Time frame: 3 study sessions/subject; each session was 25 h; blood samples obtained at the following time points: -60 min, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 23, 24, 25 h; at least one week washout period between each study session
Area under the concentration-time curve from 0 to 25 h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Audra L Stinchcomb, PhD principal investigator
University of Maryland, Baltimore School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metronidazole gel 1, Metronidazole gel 2 and Metronidazole cream in people with Bioequivalence, run by University of Maryland, Baltimore 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 20 inclusion and 20 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: finished, as of the sponsor's last update on 17 May 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PK Parameters (time frame: 3 study sessions/subject; each session was 25 h; blood samples obtained at the following time points: -60 min, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 23, 24, 25 h; at least one week washout period between each study session). 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 17 May 2022.