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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01407016
First received: July 20, 2011
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Infection
 Drug: metronidazole IV 500 mg
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma metronidazole pharmacokinetic parameters for single dose:Cmax [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Plasma metronidazole pharmacokinetic parameters for single dose:AUClast [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6 [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Plasma metronidazole pharmacokinetic parameters for single dose:Tmax [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Plasma metronidazole pharmacokinetic parameters for multiple dose:Ctrough [ Time Frame: prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8 ] [ Designated as safety issue: No ]
  • Plasma metronidazole pharmacokinetic parameters for multiple dose:Cmax [ Time Frame: Day 8 to Day 9 ] [ Designated as safety issue: No ]
  • Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6 [ Time Frame: Day 8 to Day 9 ] [ Designated as safety issue: No ]
  • Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax [ Time Frame: Day 8 to Day 9 ] [ Designated as safety issue: No ]
  • Plasma metronidazole pharmacokinetic parameters for multiple dose:CL [ Time Frame: Day 8 to Day 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Cmax [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUClast [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUC0-6 [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Tmax [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Ctrough [ Time Frame: prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8 ] [ Designated as safety issue: No ]
  • Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Cmax [ Time Frame: Day 8 to Day 9 ] [ Designated as safety issue: No ]
  • Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: AUC0-6 [ Time Frame: Day 8 to Day 9 ] [ Designated as safety issue: No ]
  • Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Tmax [ Time Frame: Day 8 to Day 9 ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.0 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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407016

Locations
Japan
Pfizer Investigational Site
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01407016     History of Changes
Other Study ID Numbers: A6831006
Study First Received: July 20, 2011
Last Updated: September 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
metronidazole infusion

Additional relevant MeSH terms:
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 16, 2013