Infection
Conditions
Keywords
metronidazole infusion
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.
Interventions
DRUGmetronidazole 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.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma metronidazole pharmacokinetic parameters for multiple dose:CL | Day 8 to Day 9 |
| Plasma metronidazole pharmacokinetic parameters for single dose:Cmax | Day 1 to Day 3 |
| Plasma metronidazole pharmacokinetic parameters for single dose:AUClast | Day 1 to Day 3 |
| Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6 | Day 1 to Day 3 |
| Plasma metronidazole pharmacokinetic parameters for single dose:Tmax | Day 1 to Day 3 |
| Plasma metronidazole pharmacokinetic parameters for multiple dose:Ctrough | prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8 |
| Plasma metronidazole pharmacokinetic parameters for multiple dose:Cmax | Day 8 to Day 9 |
| Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6 | Day 8 to Day 9 |
| Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax | Day 8 to Day 9 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUClast | Day 1 to Day 3 |
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUC0-6 | Day 1 to Day 3 |
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Tmax | Day 1 to Day 3 |
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Ctrough | prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8 |
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Cmax | Day 8 to Day 9 |
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: AUC0-6 | Day 8 to Day 9 |
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Tmax | Day 8 to Day 9 |
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Cmax | Day 1 to Day 3 |
Countries
Japan
Outcome results
None listed