Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nisoldipine · 2 trials · 1 indication
| 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 ...
Nisoldipine is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with completed trials evaluating its bioequivalence in extended-release tablet formulations. The drug is being developed by Viatris Inc. (NASDAQ: VTRS).
Nisoldipine is being developed by Viatris Inc., a pharmaceutical company traded on NASDAQ under the ticker VTRS. The company has conducted Phase 1 clinical trials for this small molecule drug in healthy volunteers.
Nisoldipine is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by the FDA.
Nisoldipine has two completed Phase 1 clinical trials: NCT00979537, a single-dose fed bioequivalence study of 40 mg extended-release tablets with 83 participants, and NCT00985660, a bioequivalence study of 30 mg extended-release tablets with 78 participants. Both trials were conducted in the United States.
Nisoldipine is being studied as a generic equivalent to Sular extended-release tablets. In clinical trial NCT00979537, nisoldipine 40 mg tablets were compared against Sular 40 mg tablets from First Horizon in a bioequivalence study.