- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01380522
Bioavailability Study of Metronidazole Capsules Under Fed Conditions
June 22, 2011 updated by: Par Pharmaceutical, Inc.
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H4N 2Y8
- Algorithme Pharma Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Subjects received kali product under fed conditions
|
Capsules, single-dose, fed
Other Names:
|
Active Comparator: B
Subjects received Searle product under fed conditions
|
Capsules, single-dose, fed
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
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%.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian Aumais, M.D, Algorithme Pharma Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2002
Primary Completion (Actual)
September 1, 2002
Study Completion (Actual)
September 1, 2002
Study Registration Dates
First Submitted
June 16, 2011
First Submitted That Met QC Criteria
June 22, 2011
First Posted (Estimate)
June 27, 2011
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 22, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTL-P2-156
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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