A Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Injection In Healthy Japanese Subjects

September 27, 2011 updated by: Pfizer

A Phase 1, Open Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Following Single And Multiple Intravenous Infusion In Healthy Japanese Adult Subjects

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of metronidazole following single and multiple intravenous infusion in healthy Japanese adult subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

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

  • Japan
      • Tokyo, Japan
        • Pfizer Investigational Site

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

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Japanese male and/or female subjects.

Exclusion Criteria:

  • Subject with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Subject with history of regular alcohol consumption exceeding 7 drink/week for females or 14 drinks/week for males [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor] within 6 months of screening.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1.0
Drug: metronidazole IV 500 mg
On Day 1, subjects will receive a single dose of 500 mg metronidazole by intravenous infusion over 20 minutes. On Day 3 to Day 7, subjects will receive multiple doses of 500 mg metronidazole by intravenous infusion over 20 minutes 4 times a day (every 6 hours) for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma metronidazole pharmacokinetic parameters for single dose:Cmax
Time Frame: Day 1 to Day 3
Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for single dose:AUClast
Time Frame: Day 1 to Day 3
Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6
Time Frame: Day 1 to Day 3
Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for single dose:Tmax
Time Frame: Day 1 to Day 3
Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for multiple dose:Ctrough
Time Frame: prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8
prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8
Plasma metronidazole pharmacokinetic parameters for multiple dose:Cmax
Time Frame: Day 8 to Day 9
Day 8 to Day 9
Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6
Time Frame: Day 8 to Day 9
Day 8 to Day 9
Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax
Time Frame: Day 8 to Day 9
Day 8 to Day 9
Plasma metronidazole pharmacokinetic parameters for multiple dose:CL
Time Frame: Day 8 to Day 9
Day 8 to Day 9

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Cmax
Time Frame: Day 1 to Day 3
Day 1 to Day 3
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUClast
Time Frame: Day 1 to Day 3
Day 1 to Day 3
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUC0-6
Time Frame: Day 1 to Day 3
Day 1 to Day 3
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Tmax
Time Frame: Day 1 to Day 3
Day 1 to Day 3
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Ctrough
Time Frame: prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8
prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Cmax
Time Frame: Day 8 to Day 9
Day 8 to Day 9
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: AUC0-6
Time Frame: Day 8 to Day 9
Day 8 to Day 9
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Tmax
Time Frame: Day 8 to Day 9
Day 8 to Day 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 29, 2011

First Posted (Estimate)

August 1, 2011

Study Record Updates

Last Update Posted (Estimate)

September 28, 2011

Last Update Submitted That Met QC Criteria

September 27, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6831006

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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