AzTrials
AzTrials

Clostridium Difficile Infection (CDI)Phase 1NCT07251127

Study of Metronidazole Delayed-Release Capsules in Comparison With Immediate-Release Tablets (Flagyl) for Safety and Pharmacokinetics

A Phase 1 study testing Delayed-release metronidazole and Immediate-release metronidazole in people with Clostridium Difficile Infection (CDI), run by Gateway Pharmaceutical LLC at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Clostridium difficile Infection (CDI) also referred to as Clostridium difficile associated diarrhea (CDAD) is an infectious disease that is commonly associated with taking broad-spectrum antimicrobials and certain cancer chemotherapy drugs, which unbalance the ecosystem of the colon causing Clostridium difficile to… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Clostridium Difficile Infection (CDI)
What is being tested?
Delayed-release metronidazole and Immediate-release metronidazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteIndia
Study dates
27 May 2025to 7 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Subjects aged between 18 and 45 years (both inclusive).
  • Subjects' weight within normal range according to normal values for Body Mass Index (between 18.5 and 30.0 kg/m2) (both inclusive) with minimum of 45 kg weight.
  • Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the normal range.
  • Subjects having normal 12-lead electrocardiogram (ECG).
  • Subjects having normal chest X-Ray (PA view), if taken.
  • Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
Show all 10Show fewer
  • Subjects having negative urine alcohol test / breath alcohol test.
  • Non-smoker.
  • Subjects willing to adhere to the protocol requirements and to provide written informed consent.
  • Subjects having negative urine pregnancy test at screening and negative serum b-hCG pregnancy test on admission day of period 01 (only for female subjects).

Who cannot join

  • Hypersensitivity to Metronidazole, nitroimidazole derivatives or related class of drugs or any of its excipients or heparin.
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
  • Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01.
  • Presence of alcoholism or drug abuse.
  • History or presence of asthma, urticaria or other significant allergic reactions.
  • Subjects with known history of Cockayne's syndrome
Show all 15Show fewer
  • History or presence of significant gastric and/or duodenal ulceration.
  • History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
  • History or presence of cancer or basal or squamous cell carcinoma.
  • Consumption of xanthine-containing products, tobacco containing products or alcohol or any alcohol containing products within 48.00 hours prior to admission in period 01.
  • Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission of period 01.
  • Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
  • History or presence of significant easy bruising or bleeding.
  • History or presence of significant recent trauma.
  • Female subjects who are currently breast feeding.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Veeda Lifesciences

    Ahmedabad, Gujarat

Other trials in India

About this study

Official title: A Single-dose, Randomized, Crossover, Comparative Bioavailability Study of 500 mg Metronidazole Delayed-release (DR) Capsules of Gateway Pharmaceutical LLC, USA and Metronidazole Tablets USP in Healthy, Adult, Human Subjects Under Fasting Condition

Clostridium difficile Infection (CDI) also referred to as Clostridium difficile associated diarrhea (CDAD) is an infectious disease that is commonly associated with taking broad-spectrum antimicrobials and certain cancer chemotherapy drugs, which unbalance the ecosystem of the colon causing Clostridium difficile to become the predominant part of the microbiota. C. difficile is a Gram-positive anaerobe, non-invasive by remaining in the colon lumen, and produces toxins A and B that cause diseases, ranging from diarrhea, to pseudomembranous colitis, toxic megacolon, colon perforation, sepsis, or death.

CDI is the leading cause of hospital-associated gastrointestinal illness, responsible for ~ 500,000 infections and 29,000 deaths each year in the US. It places a high burden on the health-care system, which costs $4.8 billion annually. Rates of CDI have been increasing since 2000, especially in the elderly with a recent hospitalization or residing in long-term care facility (LTCF). The mortality rate from CDI is 2 to 5% but increases to 10 to 20% among elderly debilitated patients, and is even greater in patients who develop severe colitis or systemic toxicity. More recently, it has become a community pathogen, affecting younger populations who were previously at low risk.

Read more

Currently there are limited medicines for treating active CDI, and no new antibiotic approvals in this area after 2011. Fidaxomicin is concerned with its cost and increased burden of resistance; Vancomycin is related to vancomycin-resistant enterococci and saved as the last resort antibiotic; metronidazole as immediate-release tablets (Flagyl) is completely absorbed from the upper GI tract into the systemic blood systems, leaving low and inconsistent drug concentrations at the colon to battle C. difficile. More treatment options are urgently needed.

Gateway Pharma has developed a 505(b)(2) new product, Metronidazole Delayed-Release (DR) Minitablets in Capsule using our patent-protected colon-targeting platform. The goal is to reduce metronidazole blood absorption and increase drug local concentrations at the colon, to achieve 1) improved efficacy and 2) reduced side effects. Our ultimate goal is to restore metronidazole as the first-line medicine for treating CDI.

Read the detailed description

To compare the absorption rate and extent of the DR Capsule with the IR Tablet, to measure the amount of metronidazole in feces and to monitor the safety and tolerability of subjects.

Being tested
Delayed-release metronidazole, Immediate-release metronidazole
Keywords
Metronidazole, Delayed-release, Phase 1, Pharmacokinetic, Clostridium difficile infection, Colon-targeting, Colon-delivery, 505b2
Medical subject headings
Clostridium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delayed-release metronidazoleDrug

    Also called 505(b)(2)

    Oral single dose, 500 mg

  • Immediate-release metronidazoleDrug

    Also called Flagyl®

    Oral single dose, 500 mg

Study groups in NCT07251127
Study groupRoleWhat they receive
Metronidazole DR CapsuleExperimentalColon-delivery
Receives: Drug: Delayed-release metronidazole
Metronidazole Tablet USPActive comparatorImmediate-release
Receives: Drug: Immediate-release metronidazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the curve

    Measured: up to 3 days

  2. Cmax

    Measured: up to 3 days

Secondary outcomes (2)

  1. Occurrence of adverse events

    Measured: up to 7 days

  2. Fecal drug level

    Measured: up to 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2025
  2. Study start27 May 2025
  3. Primary completion6 Jun 2025
  4. Study completion7 Jun 2025

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07251127
Sponsor's protocol ID
GP-MTZ DR-25-0527
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
26 Nov 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Grundfest-Broniatowski S, Quader M, Alexander F, Walsh RM, Lavery I, Milsom J. Clostridium difficile colitis in the critically ill. Dis Colon Rectum. 1996 Jun;39(6):619-23. doi: 10.1007/BF02056938.

    PubMed 8646945

  • Debast SB, Bauer MP, Kuijper EJ; European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014 Mar;20 Suppl 2:1-26. doi: 10.1111/1469-0691.12418.

    PubMed 24118601

  • Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH; Society for Healthcare Epidemiology of America; Infectious Diseases Society of America. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-55. doi: 10.1086/651706.

    PubMed 20307191

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Delayed-release metronidazole and Immediate-release metronidazole in people with Clostridium Difficile Infection (CDI), run by Gateway Pharmaceutical LLC at 1 site in India.

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 10 inclusion and 15 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 26 Nov 2025. 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 India. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Area under the curve (time frame: up to 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07251127, which also lists 3 linked publications.

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 26 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in