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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metronidazole IV 500 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Plasma metronidazole pharmacokinetic parameters for multiple dose:CL | Day 8 to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Cmax | Day 1 to Day 3 | |
| Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUClast | Day 1 to Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| 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 |