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

Bacterial Infections research study

What is the primary objective of this study?

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).

Who is eligible to participate?

Inclusion Criteria: - Age 18 to 50 years, inclusive. - Body Mass Index (BMI) range is within 18.5 - 30 Kg/m2. - Subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs. Exclusion Criteria: - Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges. - Results of laboratory tests are within the normal range except for Hb and RBC indices test that should be within the 5% of reference range and kidney function tests (Creatinine will be accepted if below reference range) that are outside the reference range. (Laboratory tests are performed not longer than two weeks before the initiation of the clinical study). - Acute infection within one week preceding first study drug administration. - History of drug or alcohol abuse. - Subject is a heavy smoker (more than 10 cigarettes per day). - Subject does not agree not to take any prescription or non-prescription drugs within the two weeks preceding the first study drug administration until donating the last sample of the study. - Subject does not agree not to take any vitamins taken for nutritional purposes within two days before first study drug administration until donating the last sample of the study. - Subject is on a special diet (for example subject is a vegetarian). - Subject consumes large quantities of alcohol or beverages containing methylxanthines e.g. caffeine (coffee, tea, cola, chocolate etc). - Subject does not agree not to consume any beverages or food containing alcohol 48 hours prior to study drug administration until donating the last sample in each respective period. - Subject does not agree not to consume any beverages or food containing methyl-xanthines e.g. caffeine (coffee, tea, cola, chocolate etc.) 24 hours prior to the study drug administration until the end of confinement period. - Subject does not agree not to consume any beverages or food containing grapefruit 7 days prior to first study drug administration until donating the last sample in the study. - Subject has a history of severe diseases which have direct impact on the study. - Participation in a bioequivalence study or in a clinical study within the last 80 days before first study drug administration. - Subject intends to be hospitalized within 3 months after first study drugs administration. - Subjects who donated blood or its derivatives in the past 3 months or who through completion of this study, would have donated more than 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year. - Subject has a history of significant asthma, peptic or gastric ulcer, sinusitis, pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, dermatologic or immunological disorders. - Subject who have been engaged in strenuous exercise at least one day prior to dosing till the last sample of each respective period. - Subject having at screening examination a pulse outside the normal range of (60-100 beat per minute) or a body temperature outside the normal range of (36.4-37.7 ○C) or a respiratory rate outside the normal range of (14-20 breath per minute) or a sitting blood pressure less than 100/60 mm Hg or more than or equal to 140/90 mm Hg. - Subject has history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bacterial Infections

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Metronidazole benzoateSingle oral dose of 400 mg

Drug:Flagyl 125 mg/5 ml oral suspensionSingle oral dose of 500 mg (20 ml suspension)

Drug:Flagyl 400 mg TabletsSingle oral dose of 400 mg

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Test Product Formula AMetronidazole benzoate

Reference Product Formula BFlagyl 125 mg/5 ml oral suspension

Reference Product Formula CFlagyl 400 mg Tablets

Study Status

Completed

Start Date: June 2014

Completed Date: June 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Plasma concentration time profiles under the curve (AUC)

Secondary Outcome: Maximum concentration (Cmax)

Study sponsors, principal investigator, and references

Principal Investigator: Naji Najib, B.Sc. Pharm

Lead Sponsor: Verisfield UK Ltd. Greek Branch

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02146209

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