Study to Determine the Equivalence of Two Products Containing Metronidazole Benzoate

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02402283
• Date of registration: 24/03/2015
• Prospective Registration: Yes
• Primary sponsor: Verisfield UK Ltd. Greek Branch
• Public title: Study to Determine the Equivalence of Two Products Containing Metronidazole Benzoate
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02402283
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

Jordan

Contacts

• Name: Abdullah Hiyari, M.D.
• Affiliation: International Pharmaceutical Research Center

• Name: Naji Naji, B.Sc. Pharm
• Affiliation: International Pharmaceutical Research Center

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 which are outside the normal range or liver function
tests (alkaline phosphatase (ALP) accepted if below reference range) that are outside
the reference range or hemoglobin (Hb) or red blood cells (RBC) indices (mean
corpuscular volume (MCV), MCH and mean corpuscular hemoglobin concentration (MCHC))
with deviation outside 5% of 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, energy drinks, 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, energy drinks, 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 drug
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.

- The subject is a pregnant or lactating female.

- 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 a history of difficulties in swallowing or any gastrointestinal disease
which could affect the drug absorption.

- Subject has a history of favism (glucose-6-phosphate dehydrogenase deficiency).



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

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Metronidazole benzoate oral granules

Drug: Flagyl 400 mg Tablets

Primary Outcome(s)

Maximum concentration (Cmax) [Time Frame: Before dosing (0 hour) and 0.25, 0.50, 0.75, 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]

Plasma concentration time profiles under the curve (AUC0-t) from zero (0) hours to time (t) [Time Frame: Before dosing (0 hour) and 0.25, 0.50, 0.75, 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)

Area Under the plasma concentration-time curve (Auc0-infinity) from zero (0) hours to infinity [Time Frame: Before dosing (0 hour) and 0.25, 0.50, 0.75, 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: Before dosing (0 hour) and 0.25, 0.50, 0.75, 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: Before dosing (0 hour) and 0.25, 0.50, 0.75, 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: 10 days]

Elimination rate constant (Kel) [Time Frame: Before dosing (0 hour) and 0.25, 0.50, 0.75, 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-GT007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors