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

Phase 1

Completed

• Conditions: Infection
• Interventions: Drug: metronidazole IV 500 mg

• Registration Number: NCT01407016
• Lead Sponsor: Pfizer

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-29
• Study Start: 2011-08
• Study First Posted: 2011-08-01
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-27
• Last Update Posted: 2011-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1.0	metronidazole IV 500 mg	-

Primary Outcome Measures

Name	Time	Method
Plasma metronidazole pharmacokinetic parameters for single dose:Cmax	Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for single dose:AUClast	Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6	Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for single dose:Tmax	Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for multiple dose:Ctrough	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	Day 8 to Day 9
Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6	Day 8 to Day 9
Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax	Day 8 to Day 9
Plasma metronidazole pharmacokinetic parameters for multiple dose:CL	Day 8 to Day 9

Secondary Outcome Measures

Name	Time	Method
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Cmax	Day 1 to Day 3
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUClast	Day 1 to Day 3
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUC0-6	Day 1 to Day 3
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Tmax	Day 1 to Day 3
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Ctrough	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	Day 8 to Day 9
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: AUC0-6	Day 8 to Day 9
Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Tmax	Day 8 to Day 9

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Tokyo, Japan