Bioavailability Study of Metronidazole Capsules Under Fasting Conditions

NCT01380509 | Completed Phase 1

• 1 other identifier: MTL-P2-155
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

To Determine the Bioequivalence Study Under Fasting

Keywords

Bioequivalence, single-dose, fasting

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  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

Study Arms (2)

A

EXPERIMENTAL

Subjects received kali product under fasting conditions

Drug: Metronidazole

B

ACTIVE COMPARATOR

Subjects received Searle product under fasting conditions

Drug: Flagyl

Interventions

Metronidazole DRUG

Capsules, single-dose, fasting

Also known as: Flagyl Capsules

A

Flagyl DRUG

Capsules, single-dose, fasting

Also known as: Metronidazole Capsules

B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Algorithme Pharma Inc: collaborator

Study Sites (1)

Algorithme Pharma

Laval, Quebec, H7V 4B4, Canada

Location

MeSH Terms

Conditions

Fasting

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christian Sicard, M.D

  Algotithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 27, 2011
• Study Start: August 1, 2002
• Primary Completion: September 1, 2002
• Study Completion: October 1, 2002
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

CA (1)