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Also known as azithromycin (AZ) microsphere
azithromycin microsphere · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Co-administer the test chloroquine (CQ) formulation (620 mg CQ base) plus microsphere azithromycin (AZ) (2000 mg) on Day 1. |
| Group 2 | ACTIVE_COMPARATOR | Co-administer the individual tablets of CQ 2 x 500 mg (600 mg CQ base) tablets plus AZ IR 4 x 500 mg tablets on Day 1. |
| Name | Type | Description |
|---|---|---|
| azithromycin (AZ) microsphere | DRUG | AZ microsphere (2000 mg) single dose on Day 1. |
| test chloroquine (CQ) formulation | DRUG | Test CQ formulation, 620 mg CQ base, single dose on Day 1. |
| azithromycin (AZ) | DRUG | AZ IR 4 x 500 mg tablets, single dose on Day 1. |
| chloroquine (CQ) | DRUG | CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1 |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG ...
Azithromycin microsphere is an investigational small molecule formulation of azithromycin being developed by Pfizer, Inc. (NYSE: PFE) for malaria prophylaxis. It is a microsphere-based version of the antibiotic azithromycin, studied in a Phase 1 trial in combination with chloroquine. It is not an approved product and remains in clinical development.
Azithromycin microsphere is being studied for malaria prophylaxis, meaning prevention of malaria infection. The Phase 1 trial enrolled healthy adult volunteers in the United States to evaluate the formulation when co-administered with chloroquine. No approved indication has been established for this microsphere formulation.
Pfizer, Inc. (NYSE: PFE) is the developer of azithromycin microsphere. The company sponsored the Phase 1 trial evaluating the formulation for malaria prophylaxis. Pfizer is a large pharmaceutical company whose ticker symbol on the New York Stock Exchange is PFE.
Azithromycin microsphere is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA for any indication, including malaria prophylaxis.
Azithromycin microsphere has been evaluated in one completed Phase 1 trial, NCT01100060. The study estimated the relative bioavailability of co-administered azithromycin microsphere and chloroquine formulations compared with co-administered immediate-release azithromycin and chloroquine tablets in 40 healthy adult subjects in the United States. It was randomized and active-controlled.
Yes. Azithromycin microsphere and azithromycin (AZ) microsphere refer to the same investigational formulation developed by Pfizer, Inc. (NYSE: PFE). The abbreviation AZ stands for azithromycin. Both names describe the microsphere-based version of azithromycin studied for malaria prophylaxis in the completed Phase 1 trial NCT01100060.