HealthyPhase 1NCT02402283
Study to Determine the Equivalence of Two Products Containing Metronidazole Benzoate
A Phase 1 study testing Metronidazole benzoate oral granules and Flagyl 400 mg Tablets in people with Healthy, run by Verisfield UK Ltd. Greek Branch at 1 site in Jordan.
Trial summary
The purpose of this study is to determine the bioequivalence of Metronidazole benzoate (400 mg metronidazole per sachet oral granules)/Terix Labs Ltd and Flagyl™ 400 mg Tablets (400 mg metronidazole per film coated tablet)/Zentiva. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Metronidazole benzoate oral granules 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
- 20 participants
- Where
- 1 siteJordan
- Study dates
- May 2015to May 2015
- 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 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.
Show all 22Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Jordan1 site
International Pharmaceutical Resaerch Center (IPRC)
Amman, Amman Governorate, 11196
About this study
Official 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
The purpose of this study is to determine the bioequivalence of Metronidazole benzoate (400 mg metronidazole per sachet oral granules)/Terix Labs Ltd and Flagyl™ 400 mg Tablets (400 mg metronidazole per film coated tablet)/Zentiva.
Read the detailed description
This study aims to compare the absorption and disposition kinetics of two products containing metronidazole under fasting conditions. These products are: Metronidazole benzoate (400 mg metronidazole per sachet oral granules)/Terix Labs Ltd, Test product manufactured by ONE PHARMA, Greece and Flagyl™ 400 mg Tablets (400 mg metronidazole per film coated tablet)/Zentiva, a Reference product manufactured by Famar Health Care Services, Spain. The bioequivalence of a single 400 mg dose of both products will be assessed by comparing the pharmacokinetic parameters derived from the plasma concentration-time profiles for metronidazole.
- Conditions
- Healthy
- Being tested
- Metronidazole benzoate oral granules, Flagyl 400 mg Tablets
- Keywords
- Bioequivalency, two metronidazole-containing products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole benzoate oral granulesDrug
Single oral dose of 400 mg
Flagyl 400 mg TabletsDrug
Single oral dose of 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Metronidazole benzoate oral granules Receives: Drug: Metronidazole benzoate oral granules |
| Reference Product | Active comparator | Flagyl 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.
Plasma concentration time profiles under the curve (AUC0-t) from zero (0) hours to time (t)
The area under the plasma concentration versus time curve, from time zero (0) to t hours
Measured: 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
Maximum concentration (Cmax)
Maximum measured plasma concentration
Measured: 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 outcomes (5)
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: 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
Elimination rate constant (Kel)
Apparent first-order elimination or terminal rate constant
Measured: 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)
The elimination or terminal half-life
Measured: 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
Area Under the plasma concentration-time curve (Auc0-infinity) from zero (0) hours to infinity
The area under the plasma concentration versus time curve from time (0) to infinity
Measured: 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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verisfield UK Ltd. Greek Branch
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naji Naji, B.Sc. Pharm, Study director, International Pharmaceutical Research CenterAbdullah Hiyari, M.D., Principal investigator, International Pharmaceutical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402283
- Sponsor's protocol ID
- MET-GT007
- Status last verified
- Jun 2015
- First submitted
- 24 Mar 2015
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02402283
- Acronym / sponsor ID
- MET-GT007
- Conditions
- Healthy
- Keywords
- Bioequivalency, two metronidazole-containing products
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Verisfield UK Ltd. Greek BranchIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the bioequivalence of Metronidazole benzoate (400 mg metronidazole per sachet oral granules)/Terix Labs Ltd and Flagyl™ 400 mg Tablets (400 mg metronidazole per film coated tablet)/Zentiva.
Detailed description
This study aims to compare the absorption and disposition kinetics of two products containing metronidazole under fasting conditions. These products are: Metronidazole benzoate (400 mg metronidazole per sachet oral granules)/Terix Labs Ltd, Test product manufactured by ONE PHARMA, Greece and Flagyl™ 400 mg Tablets (400 mg metronidazole per film coated tablet)/Zentiva, a Reference product manufactured by Famar Health Care Services, Spain. The bioequivalence of a single 400 mg dose of both products will be assessed by comparing the pharmacokinetic parameters derived from the plasma concentration-time profiles for metronidazole.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Metronidazole benzoate oral granulesMetronidazole benzoate oral granules |
| Reference Product | Active comparator | Drug: Flagyl 400 mg TabletsFlagyl 400 mg Tablets |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metronidazole benzoate oral granulesSingle oral dose of 400 mg | Drug | Test Product |
| Flagyl 400 mg TabletsSingle oral dose of 400 mg | Drug | Reference Product |
Primary outcome
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
The area under the plasma concentration versus time curve, from time zero (0) to t hours
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
Maximum measured plasma concentration
5 secondary outcomes
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
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
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
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
Number of participants with Adverse Events
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naji Naji, B.Sc. Pharm study director
International Pharmaceutical Research Center
Abdullah Hiyari, M.D. principal investigator
International Pharmaceutical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metronidazole benzoate oral granules and Flagyl 400 mg Tablets in people with Healthy, 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 22 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 23 Jun 2015. 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 (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2015.