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Study to Determine the Equivalence of Two Products Containing Metronidazole Benzoate

Healthy Clinical Trial

Official title:
Comparative Randomized, Single Dose, Two-Way Crossover Open Label Bioequivalence Study of Terix Labs Ltd Metronidazole Benzoate (400 mg Metronidazole Per Sachet Oral Granules) Versus Zentiva Flagyl™ 400 mg Tablets (400 mg Metronidazole Per Film Coated Tablet), After An Oral Administration Of 400 mg to Healthy Adults Under Fasting Conditions

Clinical Trial Summary

The purpose of this study is to determine the bioequivalence of Metronidazole benzoate (400 mg metronidazole per sachet oral granules)/Terix Labs Ltd and Flagyl™ 400 mg Tablets (400 mg metronidazole per film coated tablet)/Zentiva.

Clinical Trial Description

This study aims to compare the absorption and disposition kinetics of two products containing metronidazole under fasting conditions. These products are: Metronidazole benzoate (400 mg metronidazole per sachet oral granules)/Terix Labs Ltd, Test product manufactured by ONE PHARMA, Greece and Flagyl™ 400 mg Tablets (400 mg metronidazole per film coated tablet)/Zentiva, a Reference product manufactured by Famar Health Care Services, Spain. The bioequivalence of a single 400 mg dose of both products 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02402283
Study type Interventional
Source Verisfield UK Ltd. Greek Branch
Contact
Status Completed
Phase Phase 1
Start date May 2015
Completion date May 2015
View Details
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