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

Pfizer6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infection

Interventions

metronidazole IV 500 mgDRUG

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Plasma metronidazole pharmacokinetic parameters for single dose:Cmax

Time frame: Day 1 to Day 3

Plasma metronidazole pharmacokinetic parameters for single dose:AUClast

Time frame: Day 1 to Day 3

Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6

Time frame: Day 1 to Day 3

Plasma metronidazole pharmacokinetic parameters for single dose:Tmax

Time frame: 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

Plasma metronidazole pharmacokinetic parameters for multiple dose:Cmax

Time frame: Day 8 to Day 9

Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6

Time frame: Day 8 to Day 9

Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax

Time frame: Day 8 to Day 9

Plasma metronidazole pharmacokinetic parameters for multiple dose:CL

Time frame: Day 8 to Day 9

Secondary Outcomes

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

Time frame: Day 1 to Day 3

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.