NCT02146209

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Verisfield UK Ltd. Greek Branch · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Metronidazole benzoate	Single oral dose of 400 mg
DRUG	Flagyl 125 mg/5 ml oral suspension	Single oral dose of 500 mg (20 ml suspension)
DRUG	Flagyl 400 mg Tablets	Single oral dose of 400 mg

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-05-23
• Last updated: 2014-08-01

Locations

1 site across 1 country: Jordan