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:CmaxPlasma 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: CmaxPlasma 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
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