Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
test chloroquine formulation · 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 ...
The test chloroquine formulation is a small molecule being developed for malaria prophylaxis, the prevention of malaria infection. It is currently in Phase 1 clinical development as an investigational drug.
The test chloroquine formulation is a small molecule intended for malaria prophylaxis. Its specific molecular target is not disclosed in the available information.
The test chloroquine formulation is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE.
The test chloroquine formulation is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
The test chloroquine formulation has one completed Phase 1 clinical trial, NCT01100060, which enrolled 40 healthy adult subjects in the United States. The trial studied the relative bioavailability of the test formulation when co-administered with azithromycin microsphere compared to immediate release tablets.
The test chloroquine formulation is a specific formulation of chloroquine being studied for malaria prophylaxis. It is distinct from standard immediate release chloroquine tablets, as the trial compares their bioavailability.