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Verelan PM · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Verapamil Hydrochloride Extended-Release Capsules, 300 mg |
| 2 | ACTIVE_COMPARATOR | Verelan® PM Extended-Release Capsules, 300 mg |
| Name | Type | Description |
|---|---|---|
| Verapamil Hydrochloride Extended-Release Capsules, 300 mg | DRUG | 300mg, single dose fasting |
| Verelan® PM Extended-Release Capsules, 300 mg | DRUG | 300mg, single dose fasting |
| Verapamil HCL Extended-Release Capsules 300 mg | DRUG | 300mg, single dose fasting |
| Verelan® PM Extended-Release Capsules 300 mg | DRUG | 300mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have a negative serum (β HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administrat...
Verelan PM is an investigational small molecule being developed by Viatris Inc. (VTRS). It is a verapamil hydrochloride extended-release capsule formulation studied in healthy volunteers. As of the available data, it is in Phase 1 clinical development and is not FDA approved.
Verelan PM is being studied in healthy volunteers for pharmacokinetic comparisons. The clinical trials evaluate fasting, food, and applesauce administration of Verapamil HCl Extended-Release Capsules 300 mg against Verelan PM Extended-Release Capsules 300 mg. It is not approved for any specific disease indication.
Verelan PM is developed by Viatris Inc., a company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to compare the pharmacokinetics of Verelan PM with a reference verapamil HCl extended-release formulation.
Verelan PM is in Phase 1 clinical development. All four completed trials are Phase 1 studies in healthy volunteers. The drug is investigational and has not received FDA approval.
Verelan PM has four completed Phase 1 trials: NCT00647673 (fasting study, 24 participants), NCT00648050 (fasting study, 72 participants), NCT00648401 (food study, 24 participants), and NCT00649805 (fasting applesauce study, 24 participants). All were conducted in the United States with healthy adults aged 18 and older.
Verelan PM is a branded extended-release verapamil HCl capsule being compared to a reference Verapamil HCl Extended-Release Capsules 300 mg in clinical trials. The studies assess bioequivalence between the two formulations under fasting, fed, and applesauce conditions.