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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00985660 | Bioequivalence Study of Nisoldipine Extended-Release Tablets, 30 mg | PHASE1 | COMPLETED | 78 | — | — | Jun 1, 2007 | Jul 1, 2007 | Sep 28, 2009 | 1 | United States |
| NCT00979537 | Single-Dose Fed Bioequivalence Study of Nisoldipine Extended-Release Tablets (40 mg; Mylan) and Sular® Extended-Release Tablets (40 mg; First Horizon) in Healthy Volunteers | PHASE1 | COMPLETED | 83 | — | — | Mar 1, 2007 | Mar 1, 2007 | Sep 18, 2009 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Test: | EXPERIMENTAL | Nisoldipine ER Tablets, 30 mg |
| Reference | ACTIVE_COMPARATOR | Sular Extended-release Tablets, 30 mg |
| Test: Nisoldipine ER Tablets, 40 mg | EXPERIMENTAL | Nisoldipine Extended-release Tablets, 40 mg |
| Reference: Sular Tablets 40 mg | ACTIVE_COMPARATOR | Sular Tablets, 40 mg |
| Name | Type | Description |
|---|---|---|
| Nisoldipine Extended-release Tablets, 30 mg | DRUG | 1 x 30 mg Tablet under fasting conditions |
| Sular® Extended Release Tablets, 30 mg | DRUG | 1 x 30 mg Tablet under fasting conditions |
| Nisoldipine Extended-release Tablets, 40 mg | DRUG | - |
| Sular Tablets, 40 mg | DRUG | - |
Inclusion Criteria: * Age: 18 years and older. * Sex: Male and/or non-pregnant, non-lactating female. * Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening ...