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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02322658 | Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions | PHASE1 | COMPLETED | 46 | — | — | Sep 1, 2008 | Oct 1, 2008 | Dec 23, 2014 | 1 | India |
| NCT02322645 | Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting Conditions | PHASE1 | COMPLETED | 46 | — | — | Aug 1, 2008 | Oct 1, 2008 | Dec 23, 2014 | 1 | India |
| Arm | Type | Description |
|---|---|---|
| Eszopiclone Tablets | EXPERIMENTAL | Eszopiclone Tablets 3 mg of Dr. Reddy's Laboratories Limited |
| Lunesta | ACTIVE_COMPARATOR | Lunesta Tablets 3 mg of Sepracor Inc. |
| Name | Type | Description |
|---|---|---|
| Eszopiclone Tablets 3 mg | DRUG | - |
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...