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Bacterial InfectionsPhase 1NCT02146209

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

A Phase 1 study testing Metronidazole benzoate, Flagyl 125 mg/5 ml oral suspension and Flagyl 400 mg Tablets in people with Bacterial Infections, run by Verisfield UK Ltd. Greek Branch at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Bacterial Infections
What is being tested?
Metronidazole benzoate, Flagyl 125 mg/5 ml oral suspension and Flagyl 400 mg Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteJordan
Study dates
Jun 2014to Jun 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • International Pharmaceutical Research Center (IPRC)

    Amman, 963166

Other trials in Jordan

About this study

Official 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

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).

Read the detailed description

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.

Being tested
Metronidazole benzoate, Flagyl 125 mg/5 ml oral suspension, Flagyl 400 mg Tablets
Medical subject headings
Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metronidazole benzoateDrug

    Single oral dose of 400 mg

  • Flagyl 125 mg/5 ml oral suspensionDrug

    Single oral dose of 500 mg (20 ml suspension)

  • Flagyl 400 mg TabletsDrug

    Single oral dose of 400 mg

Study groups in NCT02146209
Study groupRoleWhat they receive
Test Product Formula AExperimentalMetronidazole benzoate
Receives: Drug: Metronidazole benzoate
Reference Product Formula BActive comparatorFlagyl 125 mg/5 ml oral suspension
Receives: Drug: Flagyl 125 mg/5 ml oral suspension
Reference Product Formula CActive comparatorFlagyl 400 mg Tablets
Receives: Drug: Flagyl 400 mg Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma concentration time profiles under the curve (AUC)

    The area under the plasma concentration versus time curve

    Measured: 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)

  1. Maximum concentration (Cmax)

    Maximum measured plasma concentration

    Measured: 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

  2. 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

    Measured: 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

  3. Elimination rate constant (Kel)

    Apparent first-order elimination or terminal rate constant

    Measured: 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

  4. Terminal half life (t1/2)

    The elimination or terminal half-life

    Measured: 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

  5. Number of participants with Adverse Events

    Subjects will be monitored throughout the study for Adverse Events

    Measured: 17 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02146209
Sponsor's protocol ID
MET-GST006
Status last verified
Jul 2014
First submitted
16 May 2014
Last updated
1 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Metronidazole benzoate, Flagyl 125 mg/5 ml oral suspension and Flagyl 400 mg Tablets in people with Bacterial Infections, run by Verisfield UK Ltd. Greek Branch at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02146209.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.

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