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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02146209
• Date of registration: 16/05/2014
• Prospective Registration: Yes
• Primary sponsor: Verisfield UK Ltd. Greek Branch
• Public title: Study to Determine the Equivalence of Three Products Containing Metronidazole Benzoate.
• Scientific 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
• Date of first enrolment: June 2014
• Target sample size: 6
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02146209
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Jordan

Contacts

• Name: Abdullah Hiyari, MD
• Affiliation: IPRC Jordan

• Name: Naji Najib, B.Sc. Pharm
• Affiliation: IPRC Jordan

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bacterial Infections

Intervention(s)

Drug: Metronidazole benzoate

Drug: Flagyl 125 mg/5 ml oral suspension

Drug: Flagyl 400 mg Tablets

Primary Outcome(s)

Plasma concentration time profiles under the curve (AUC) [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]

Secondary Outcome(s)

Maximum concentration (Cmax) [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 [Time Frame: 17 days]

Elimination rate constant (Kel) [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) [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 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]

Secondary ID(s)

MET-GST006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors