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

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ClinicalTrials.gov Identifier: NCT01407016
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : September 28, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infection Drug: metronidazole IV 500 mg Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Plasma metronidazole pharmacokinetic parameters for single dose:Cmax [ Time Frame: Day 1 to Day 3 ]
  2. Plasma metronidazole pharmacokinetic parameters for single dose:AUClast [ Time Frame: Day 1 to Day 3 ]
  3. Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6 [ Time Frame: Day 1 to Day 3 ]
  4. Plasma metronidazole pharmacokinetic parameters for single dose:Tmax [ Time Frame: Day 1 to Day 3 ]
  5. 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 ]
  6. Plasma metronidazole pharmacokinetic parameters for multiple dose:Cmax [ Time Frame: Day 8 to Day 9 ]
  7. Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6 [ Time Frame: Day 8 to Day 9 ]
  8. Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax [ Time Frame: Day 8 to Day 9 ]
  9. Plasma metronidazole pharmacokinetic parameters for multiple dose:CL [ Time Frame: Day 8 to Day 9 ]

Secondary Outcome Measures :
  1. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Cmax [ Time Frame: Day 1 to Day 3 ]
  2. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUClast [ Time Frame: Day 1 to Day 3 ]
  3. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUC0-6 [ Time Frame: Day 1 to Day 3 ]
  4. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Tmax [ Time Frame: Day 1 to Day 3 ]
  5. 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 ]
  6. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Cmax [ Time Frame: Day 8 to Day 9 ]
  7. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: AUC0-6 [ Time Frame: Day 8 to Day 9 ]
  8. Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Tmax [ Time Frame: Day 8 to Day 9 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407016


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

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01407016    
Other Study ID Numbers: A6831006
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: September 2011
Keywords provided by Pfizer:
metronidazole infusion
Additional relevant MeSH terms:
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Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents