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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
The purpose of the study is to assess whether there is any pharmacokinetic interactions between CAZ-AVI and metronidazole.
A Phase I, Open-Label, 3-way Crossover, Pharmacokinetic and Drug-Drug Interaction Study of ceftazidime avibactam (CAZ-AVI) and Metronidazole when Administered Alone and in Combination in Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAZAVI | Experimental | CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) |
|
| Metronidazole | Active Comparator | Metronidazole (500 mg) |
|
| CAZAVI+metronidazole | Active Comparator | CAZ-AVI (2000mg ceftazidime/500 mg avibactam) + metronidazole (500 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAZ-AVI | Drug | Infusion |
| |
| metronidazole |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components | CAZ-AVI: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.5, 2.75, 3, 4, 5, 7, 11, 23, 73, 73.5, 74, 74.5, 75, 75.25, 75.5, 75.75, 76, 77, 78, 80, 84 and 95 hours post-dose | |
| Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components | Metronidazole: pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 72, 72.5, 73, 73.25, 73.5, 74, 75, 76, 78, 80, 84 and 96 hours post-dose | |
| Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components | CAZ-AVI and metronidazole: pre-dose, 0.5, 1, 1.25, 1.5, 2.5, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 24, 72, 72.5, 73, 73.25, 73.5, 74, 74.5, 75, 75.25, 75.5, 75.75, 76, 77, 78, 80, 84 and 96 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety and tolerability of CAZ-AVI and metronidazole when administered as a 2- and 1-hour infusion, respectively, every 8 hours by assessment of adverse events, lab, vital signs, ECG, physical examination | Screening up to 26 days after first dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mirjana Kujacic, MD | AstraZenecaMolndal Sweden | Study Chair |
| David Mathews, MD | QuintilesOverland Park, US | Principal Investigator |
| Paul Newell | Astrazeneca Alderly UK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26516584 | Background | Das S, Li J, Armstrong J, Learoyd M, Edeki T. Randomized pharmacokinetic and drug-drug interaction studies of ceftazidime, avibactam, and metronidazole in healthy subjects. Pharmacol Res Perspect. 2015 Oct;3(5):e00172. doi: 10.1002/prp2.172. Epub 2015 Aug 25. |
| Label | URL |
|---|---|
| Redaction of D4280C00012 Protocol | View source |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Drug |
Infusion |
|
| CAZ-AVI + metronidazole | Drug | Infusion |
|
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |