Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01100060 | A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects | PHASE1 | COMPLETED | 40 | — | — | Apr 1, 2010 | Jun 1, 2010 | Aug 25, 2010 | 1 | United States |
| 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 ...