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

NCT02146209 | Completed Phase 1

• 1 other identifier: MET-GST006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Plasma concentration time profiles under the curve (AUC)

  The area under the plasma concentration versus time curve

  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 Outcomes (5)

• Maximum concentration (Cmax)

  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)

  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)

  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)

  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

  17 days

Study Arms (3)

Test Product Formula A

EXPERIMENTAL

Metronidazole benzoate

Drug: Metronidazole benzoate

Reference Product Formula B

ACTIVE COMPARATOR

Flagyl 125 mg/5 ml oral suspension

Drug: Flagyl 125 mg/5 ml oral suspension

Reference Product Formula C

ACTIVE COMPARATOR

Flagyl 400 mg Tablets

Drug: Flagyl 400 mg Tablets

Interventions

Metronidazole benzoate DRUG

Single oral dose of 400 mg

Test Product Formula A

Flagyl 125 mg/5 ml oral suspension DRUG

Single oral dose of 500 mg (20 ml suspension)

Reference Product Formula B

Flagyl 400 mg Tablets DRUG

Single oral dose of 400 mg

Reference Product Formula C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Verisfield UK Ltd. Greek Branch: lead

Study Sites (1)

International Pharmaceutical Research Center (IPRC)

Amman, 963166, Jordan

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Benchmarking; Metronidazole; Suspensions

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Naji Najib, B.Sc. Pharm

  IPRC Jordan

  STUDY DIRECTOR

• Abdullah Hiyari, MD

  IPRC Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 23, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 1, 2014

Record last verified: 2014-07

Locations

JO (1)