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Bioavailability Study of Metronidazole Capsules Under Fed Conditions

This study has been completed.
Sponsor:
Collaborator:
Algorithme Pharma Inc
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT01380522
First received: June 16, 2011
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D. Searle, Inc.


Condition Intervention Phase
To Determine the Bioequivalence Study Under Fed
 Drug: Metronidazole
Drug: Flagyl
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]
    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%.


Enrollment: 18
Study Start Date: August 2002
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Subjects received kali product under fed conditions
 Drug: Metronidazole
Capsules, single-dose, fed
Other Name: Flagyl
Active Comparator: B
Subjects received Searle product under fed conditions
 Drug: Flagyl
Capsules, single-dose, fed
Other Name: Metronidazole Capsules

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380522

Locations
Canada, Quebec
Algorithme Pharma Inc
Montreal, Quebec, Canada, H4N 2Y8
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Algorithme Pharma Inc
Investigators
Principal Investigator: Christian Aumais, M.D Algorithme Pharma Inc
  More Information

No publications provided

Responsible Party: Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT01380522     History of Changes
Other Study ID Numbers: MTL-P2-156
Study First Received: June 16, 2011
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Par Pharmaceutical, Inc.:
Bioequivalence, single-dose, fed

Additional relevant MeSH terms:
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 23, 2013