NCT07251127

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Gateway Pharmaceutical LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 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. 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.

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.

Conditions

• Clostridium Difficile Infection (CDI)

Interventions

Type	Name	Description
DRUG	Delayed-release metronidazole	Oral single dose, 500 mg
DRUG	Immediate-release metronidazole	Oral single dose, 500 mg

Timeline

• Start date: 2025-05-27
• Primary completion: 2025-06-06
• Completion: 2025-06-07
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study