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

NCT ID: NCT01407016

Last Updated: 2011-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1.0

Group Type EXPERIMENTAL

metronidazole IV 500 mg

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6831006&StudyName=A%20Study%20To%20Assess%20The%20Safety%2C%20Tolerability%20And%20Pharmacokinetics%20Of%20Metronidazole%20Injection%20In%20Healthy%20Japanese%20Subjects

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6831006

Identifier Type: -

Identifier Source: org_study_id