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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection

Intervention: metronidazole IV 500 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

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

Primary outcome:

Plasma metronidazole pharmacokinetic parameters for single dose:Cmax

Plasma metronidazole pharmacokinetic parameters for single dose:AUClast

Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6

Plasma metronidazole pharmacokinetic parameters for single dose:Tmax

Plasma metronidazole pharmacokinetic parameters for multiple dose:Ctrough

Plasma metronidazole pharmacokinetic parameters for multiple dose:Cmax

Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6

Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax

Plasma metronidazole pharmacokinetic parameters for multiple dose:CL

Secondary outcome:

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

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

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

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

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

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

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

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

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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 and Contacts

Pfizer Investigational Site, Tokyo, Japan
Additional Information

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

Starting date: August 2011
Last updated: September 27, 2011

Page last updated: August 23, 2015

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