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

Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407016
• Other study ID #: A6831006
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2011
• Last updated: September 27, 2011
• Start date: August 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection

Intervention

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.

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma metronidazole pharmacokinetic parameters for single dose:Cmax		Day 1 to Day 3	No
Primary	Plasma metronidazole pharmacokinetic parameters for single dose:AUClast		Day 1 to Day 3	No
Primary	Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6		Day 1 to Day 3	No
Primary	Plasma metronidazole pharmacokinetic parameters for single dose:Tmax		Day 1 to Day 3	No
Primary	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	No
Primary	Plasma metronidazole pharmacokinetic parameters for multiple dose:Cmax		Day 8 to Day 9	No
Primary	Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6		Day 8 to Day 9	No
Primary	Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax		Day 8 to Day 9	No
Primary	Plasma metronidazole pharmacokinetic parameters for multiple dose:CL		Day 8 to Day 9	No
Secondary	Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Cmax		Day 1 to Day 3	No
Secondary	Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUClast		Day 1 to Day 3	No
Secondary	Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUC0-6		Day 1 to Day 3	No
Secondary	Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Tmax		Day 1 to Day 3	No
Secondary	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	No
Secondary	Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Cmax		Day 8 to Day 9	No
Secondary	Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: AUC0-6		Day 8 to Day 9	No
Secondary	Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Tmax		Day 8 to Day 9	No

External Links

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