To Determine the Bioequivalence Study Under FedPhase 1NCT01380522
Bioavailability Study of Metronidazole Capsules Under Fed Conditions
A Phase 1 study testing Metronidazole and Flagyl in people with To Determine the Bioequivalence Study Under Fed, run by Par Pharmaceutical, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D. Searle, Inc. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- To Determine the Bioequivalence Study Under Fed
- What is being tested?
- Metronidazole and Flagyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2002to Sep 2002
- 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
- Subjects meeting all the following criteria may be included in the study
- Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject.
- Males or females aged from 18 to 50 years with a body mass index (BMI) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the Case Report Forms (CRF) (laboratory tests are presented in section 7.1.3)
- Healthy according to the laboratory results and physical examination
- Subjects should be non-or ex-smokers
Who cannot join
- Significant history of hypersensitivity to metronidazole or any related products as well as sever hypersensitivity reactions (like angioedema) to any drugs.
- Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
- Females who are pregnant, lactating or are likely to become pregnant during the study periods.
- Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the study.
- Positive pregnancy test before or during the study.
Show all 18Show fewer
- Presence or history of significant thyroid dysfunction (hypo or hyperthyroidism).
- Presence or history of significant hypoadrenalism.
- Presence or history of significant blood disorders (thrombocytopenia, hemophilia, bleeding, etc.).
- Presence or history of significant neurological disorders.
- Maintenance therapy with any drug, or significant history of drug dependency, alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease.
- Any clinically significant illness in the previous 28 days before day 1 of this study.
- Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
- Participation in another clinical trial in the previous 28 days before day 1 of this study.
- Donation of 500mL of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 5 days before day 1 of this study.
- Positive urine screening of drugs of abuse (drug names are presented in section 7.1.4.).
- Positive results to HIV, HBsAg or anti-HCV tests.
- History of fainting upon blood sampling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Relative Bioavailability of 375 mg Metronidazole Capsules (Kali) With That of Flagyl 375 mg Capsules/( G.D. Searle, Inc) Under Fed Conditions
The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D. Searle, Inc.
Read the detailed description
To compare the relative Bioavailability of Metronidazole 375 mg Capsules with that of Flagyl 375 mg Capsules in healthy, adult subjects under fed conditions
- Being tested
- Metronidazole, Flagyl
- Keywords
- Bioequivalence, single-dose, fed
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called Flagyl
Capsules, single-dose, fed
FlagylDrug
Also called Metronidazole Capsules
Capsules, single-dose, fed
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received kali product under fed conditions Receives: Drug: Metronidazole |
| B | Active comparator | Subjects received Searle product under fed conditions Receives: Drug: Flagyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
To conclude bioequivalence the exponential of the difference between the test and reference product for Cmax, AUCt and AUC∞ should be between 80 and 125%.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startAug 2002
- Primary completionSep 2002
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine the Bioequivalence Study Under FedStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma Inc
- Investigators
- Christian Aumais, M.D, Principal investigator, Algorithme Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380522
- Sponsor's protocol ID
- MTL-P2-156
- Status last verified
- Jun 2011
- First submitted
- 16 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Relative Bioavailability of 375 mg Metronidazole Capsules (Kali) With That of Flagyl 375 mg Capsules/( G.D. Searle, Inc) Under Fed Conditions
- ClinicalTrials.gov ID
- NCT01380522
- Acronym / sponsor ID
- MTL-P2-156
- Keywords
- Bioequivalence, single-dose, fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma Inc
- Study start
- Aug 2002
- Primary completion
- Sep 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 27 Jun 2011 (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 compare the single-dose Bioavailability of Kali and G.D. Searle, Inc.
Detailed description
To compare the relative Bioavailability of Metronidazole 375 mg Capsules with that of Flagyl 375 mg Capsules in healthy, adult subjects under fed conditions
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MetronidazoleSubjects received kali product under fed conditions |
| B | Active comparator | Drug: FlagylSubjects received Searle product under fed conditions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects meeting all the following criteria may be included in the study
- Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject.
- Males or females aged from 18 to 50 years with a body mass index (BMI) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the Case Report Forms (CRF) (laboratory tests are presented in section 7.1.3)
- Healthy according to the laboratory results and physical examination
Key exclusion criteria (18 listed)
- Significant history of hypersensitivity to metronidazole or any related products as well as sever hypersensitivity reactions (like angioedema) to any drugs.
- Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
- Females who are pregnant, lactating or are likely to become pregnant during the study periods.
- Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the study.
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 |
|---|---|---|
| MetronidazoleAlso: FlagylCapsules, single-dose, fed | Drug | A |
| FlagylAlso: Metronidazole CapsulesCapsules, single-dose, fed | Drug | B |
Primary outcome
Bioequivalence
To conclude bioequivalence the exponential of the difference between the test and reference product for Cmax, AUCt and AUC∞ should be between 80 and 125%.
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 27 Jun 2011.
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.
Christian Aumais, M.D principal investigator
Algorithme Pharma Inc
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 and Flagyl in people with To Determine the Bioequivalence Study Under Fed, run by Par Pharmaceutical, Inc. at 1 site in Canada.
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 6 inclusion and 18 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 27 Jun 2011. 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 Canada. 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?
Bioequivalence. 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 27 Jun 2011.