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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

July 20, 2011
September 27, 2011
August 2011
September 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01407016 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole parmacokinetic 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 parmacokinetic 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 parmacokinetic 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 parmacokinetic 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 parmacokinetic 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 parmacokinetic 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 parmacokinetic 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 parmacokinetic parameters for multiple dose: Tmax [ Time Frame: Day 8 to Day 9 ] [ Designated as safety issue: No ]
 
 
 
A Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Injection In Healthy Japanese Subjects
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

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.
 
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Infection
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.
Experimental: 1.0
Intervention: Drug: metronidazole IV 500 mg
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01407016
A6831006
 
Pfizer
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP