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The primary objective is to estimate the relative bioavailability of fixed azithromycin / chloroquine combination tablets relative to co-administered individual tablets of azithromycin and chloroquine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Two of the fixed combination tablets each containing 250 mg of azithromycin and 155 mg of chloroquine base. |
|
| Treatment B | Active Comparator | A single tablet containing 500 mg of azithromycin and a single tablet containing 300 mg of chloroquine base. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed combination of Azithromycin and Chloroquine | Drug | Pfizer will provide the study medications, fixed combination azithromycin/chloroquine tablets (250 mg/155 mg, base), The study treatment is single dose. |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast and Cmax of azithromycin and chloroquine for each treatment. | up to 96 hours post dose on Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of azithromycin and chloroquine for each treatment cohort. | up to 96 hours post dose on Day 5 |
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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 | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Azithromycin and Chloroquine | Drug | Pfizer will provide Zithromax (500 mg) and Aralen (500 mg containing 300 mg chloroquine base). The study treatment is single dose. |
|
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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