Status:
COMPLETED
A Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Injection In Healthy Japanese Subjects
Lead Sponsor:
Pfizer
Conditions:
Infection
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy Japanese male and/or female subjects.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01407016
Start Date
August 1 2011
End Date
September 1 2011
Last Update
September 28 2011
Active Locations (1)
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1
Pfizer Investigational Site
Tokyo, Japan