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VoSpire · 3 trials · 1 indication
| 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...
VoSpire is an investigational small molecule being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development. VoSpire is being studied in healthy volunteers, and all three completed trials have focused on bioequivalence and pharmacokinetic assessments.
VoSpire is being studied in healthy volunteers as part of Phase 1 clinical trials. The completed trials have evaluated the bioequivalence of albuterol sulfate extended-release tablets and nisoldipine extended-release tablets. The drug is not yet approved and remains in clinical development.
VoSpire is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. Viatris is conducting the Phase 1 clinical trials for VoSpire in the United States.
VoSpire is in Phase 1 clinical development. All three clinical trials associated with VoSpire have been completed, with a total enrollment of 90 healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
VoSpire has been studied in three completed Phase 1 trials: NCT00649779 (fasting study of albuterol sulfate extended-release tablets), NCT00649987 (fed study of albuterol sulfate extended-release tablets), and NCT00730197 (fasting bioequivalence study of nisoldipine extended-release tablets). All trials were conducted in the United States with healthy volunteers.
VoSpire is a branded extended-release formulation of albuterol sulfate. The clinical trials for VoSpire compared the test product to VoSpire ER tablets, confirming that VoSpire is an albuterol sulfate extended-release product. It is distinct from immediate-release albuterol formulations.