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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02291341 | Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed Condition | PHASE1 | COMPLETED | 76 | — | — | May 1, 2008 | May 1, 2008 | Nov 14, 2014 | 1 | India |
| NCT02291367 | Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition | PHASE1 | COMPLETED | 76 | — | — | May 1, 2008 | May 1, 2008 | Nov 14, 2014 | 1 | India |
| Arm | Type | Description |
|---|---|---|
| Duloxetine Delayed-Release Capsules, 60 mg | EXPERIMENTAL | Duloxetine Delayed-Release Capsules, 60 mg of Dr. Reddys Laboratories Limited |
| Cymbalta | ACTIVE_COMPARATOR | Cymbalta® 60 mg capsule of Eli Lilly and Company |
| Name | Type | Description |
|---|---|---|
| Duloxetine | DRUG | Duloxetine Delayed-Release Capsules 60 mg |
| Cymbalta® | DRUG | 60 mg capsule of Eli Lilly and Company |
Inclusion Criteria: 1. The subjects should be healthy human between 18 and 45 years. 2. The subjects should be screened within 21 days prior to the administration of first dose of the study drug. 3. The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter. 4. The subjects...