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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Single oral dose of 400 mg
Single oral dose of 500 mg (20 ml suspension)
Single oral dose of 400 mg
International Pharmaceutical Research Center (IPRC)
Amman, Jordan
Plasma concentration time profiles under the curve (AUC)
The area under the plasma concentration versus time curve
Time frame: 0, 15, 30 and 45 minutes and 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Maximum concentration (Cmax)
Maximum measured plasma concentration
Time frame: 0, 15, 30 and 45 minutes and 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Time to maximum concentration (Tmax)
Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value
Time frame: 0, 15, 30 and 45 minutes and 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Elimination rate constant (Kel)
Apparent first-order elimination or terminal rate constant
Time frame: 0, 15, 30 and 45 minutes and 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Terminal half life (t1/2)
The elimination or terminal half-life
Time frame: 0, 15, 30 and 45 minutes and 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Number of participants with Adverse Events
Subjects will be monitored throughout the study for Adverse Events
Time frame: 17 days
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