Clinical Trials Logo
  1. Home
  2. Bacterial Infections
  3. NCT02146209

Study to Determine the Equivalence of Three Products Containing Metronidazole Benzoate.

Bacterial Infections Clinical Trial

Official title:
Comparative Randomized, Single Dose, Three-Period Crossover Open-Label Study to Determine the Bioequivalence Of Terix Labs Ltd Metronidazole Benzoate (400 mg Metronidazole Per Sachet Oral Granules (Formula A)) Relative to 500 mg From Sanofi-aventis Flagyl 125 mg/5 ml (125 mg Metronidazole Per 5 ml Suspension (Formula B)) and Zentiva Flagyl™ 400 mg Tablets (400 mg Metronidazole Per Film Coated Tablets (Formula C)) , After an Oral Administration to Healthy Adults Under Fasting Conditions

Clinical Trial Summary

The purpose of this study is to determine whether Terix Labs Ltd Metronidazole benzoate (400 mg Metronidazole Per Sachet Oral Granules) is bioequivalent to 500 mg Sanofi-aventis Flagyl 125 mg/5 ml (125 mg Metronidazole Per 5 ml Suspension) and to Zentiva Flagyl™ 400 mg Tablets (400 mg Metronidazole Per Film Coated Tablets).

Clinical Trial Description

This study is a pilot study exploited for exploratory purposes to compare the absorption and disposition kinetics of three products containing metronidazole under fasting conditions. These products are: Metronidazole benzoate (formula A), Test product manufactured by ONE PHARMA, Greece. Flagyl 125 mg/5 ml (formula B), a Reference product manufactured by Unither Liquid Manufacturing, France and Flagyl™ 400 mg Tablets (formula C), a Reference product manufactured by Famar Health Care Services, Spain. The bioequivalence of a single 400 mg dose of products A and C, and a single 500 mg dose of product B will be assessed by comparing the pharmacokinetic parameters derived from the plasma concentration-time profiles for metronidazole. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02146209
Study type Interventional
Source Verisfield UK Ltd. Greek Branch
Contact
Status Completed
Phase Phase 1
Start date June 2014
Completion date June 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT03726216 - Xydalba Utilization Registry in France
Completed NCT03605498 - OR PathTrac (Tracking Intra-operative Bacterial Transmission)
Withdrawn NCT05269121 - Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections Phase 1/Phase 2
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Recruiting NCT02074865 - Children's Antibiotic Resistant Infections in Low Income Countries N/A
Completed NCT01689207 - To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) Phase 1
Completed NCT01932034 - Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software N/A
Completed NCT01412801 - Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings Phase 2
Not yet recruiting NCT01159470 - The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children N/A
Completed NCT00983255 - Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA) Phase 1
Completed NCT00799591 - French Study In ICU Patients Treated With Tigecycline N/A
Completed NCT00678106 - Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections Phase 1
Completed NCT01074775 - Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection N/A
Completed NCT00478855 - Tazocin Intervention Study Phase 4
Terminated NCT00431028 - Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery Phase 1/Phase 2
Not yet recruiting NCT03634904 - Serum Ceftazidime Concentrations in Hemodialysis Patients N/A
Recruiting NCT05684705 - Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 Phase 1
Recruiting NCT03858387 - PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
Enrolling by invitation NCT04764058 - Efficacy and Safety of Colistin Based Antibiotic Therapy Phase 1/Phase 2
Recruiting NCT06319235 - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® Phase 1/Phase 2