Bioavailability Study of Metronidazole Capsules Under Fasting Conditions

This study has been completed.
Sponsor:
Collaborator:
Algorithme Pharma Inc
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT01380509
First received: June 16, 2011
Last updated: June 22, 2011
Last verified: June 2011
  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 Fasting
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 Fasting Conditions

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]
    To conclude bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax


Enrollment: 28
Study Start Date: August 2002
Study Completion Date: October 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Subjects received kali product under fasting conditions
Drug: Metronidazole
Capsules, single-dose, fasting
Other Name: Flagyl Capsules
Active Comparator: B
Subjects received Searle product under fasting conditions
Drug: Flagyl
Capsules, single-dose, fasting
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 fasting 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 weight 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380509

Locations
Canada, Quebec
Algorithme Pharma
Laval, Quebec, Canada, H7V 4B4
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Algorithme Pharma Inc
Investigators
Principal Investigator: Christian Sicard, M.D Algotithme Pharma Inc
  More Information

No publications provided

Responsible Party: Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc
ClinicalTrials.gov Identifier: NCT01380509     History of Changes
Other Study ID Numbers: MTL-P2-155
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, fasting

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 July 26, 2014