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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00730197 | Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mg | PHASE1 | COMPLETED | 48 | — | — | Feb 1, 2007 | Mar 1, 2007 | Aug 8, 2008 | 1 | United States |
| NCT00649779 | Fasting Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg | PHASE1 | COMPLETED | 21 | — | — | Sep 1, 2005 | Oct 1, 2005 | Apr 1, 2008 | 1 | United States |
| NCT00649987 | Fed Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg | PHASE1 | COMPLETED | 21 | — | — | Sep 1, 2005 | Oct 1, 2005 | Apr 24, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | NISOLDIPINE EXTENDED-RELEASE TABLETS, 40 MG |
| 2 | ACTIVE_COMPARATOR | Sular® Extended Release 40 mg tablets |
| Name | Type | Description |
|---|---|---|
| Albuterol Sulfate Extended-Release Tablets 8 mg | DRUG | 8mg, single dose fed |
| VoSpire® ER Tablets 8 mg | DRUG | 8mg, single dose fed |
| albuterol sulfate extended-release 8 mg tablets | DRUG | 8mg, single dose fasting |
| VoSpire™ ER 8 mg tablets | DRUG | 8mg, single dose fasting |
I. Inclusion Criteria: Subjects who met the following criteria were included in the study. 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test perfor...