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OpenTrials
Completed

NCT Number: NCT01407016

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

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Key information

Conditions

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metronidazole IV 500 mg

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.

Primary outcomes

  1. Plasma metronidazole pharmacokinetic parameters for single dose:Cmax

    Time frame: Day 1 to Day 3

  2. Plasma metronidazole pharmacokinetic parameters for single dose:AUClast

    Time frame: Day 1 to Day 3

  3. Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6

    Time frame: Day 1 to Day 3

  4. Plasma metronidazole pharmacokinetic parameters for single dose:Tmax

    Time frame: Day 1 to Day 3

  5. 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

  6. Plasma metronidazole pharmacokinetic parameters for multiple dose:Cmax

    Time frame: Day 8 to Day 9

  7. Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6

    Time frame: Day 8 to Day 9

  8. Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax

    Time frame: Day 8 to Day 9

  9. Plasma metronidazole pharmacokinetic parameters for multiple dose:CL

    Time frame: Day 8 to Day 9

Secondary outcomes

  1. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Cmax

    Time frame: Day 1 to Day 3

  2. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUClast

    Time frame: Day 1 to Day 3

  3. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUC0-6

    Time frame: Day 1 to Day 3

  4. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Tmax

    Time frame: Day 1 to Day 3

  5. 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

  6. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Cmax

    Time frame: Day 8 to Day 9

  7. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: AUC0-6

    Time frame: Day 8 to Day 9

  8. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Tmax

    Time frame: Day 8 to Day 9

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 1, 2011
Registry last updated
Sep 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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