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Extended Phenytoin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Extended Phenytoin Sodium Capsules 100 mg |
| 2 | ACTIVE_COMPARATOR | Dilantin® Kapseals® 100 mg |
| Name | Type | Description |
|---|---|---|
| Extended Phenytoin Sodium Capsules 100 mg | DRUG | 3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16 |
| Dilantin® Kapseals® 100 mg | DRUG | 3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16 |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or females of non-childbearing potential. 1. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history: 1. postmenopausal with an absence of menses for ...
Extended Phenytoin is an investigational small molecule developed by Viatris Inc. (ticker VTRS). It is also known as Extended Phenytoin Sodium Capsules 100 mg. The drug is in Phase 1 clinical development, with one completed trial. The specific medical condition it is intended to treat has not been disclosed.
Extended Phenytoin is being developed by Viatris Inc., which trades on the Nasdaq under the ticker VTRS. Viatris is the sponsor of the clinical program for this investigational small molecule.
Extended Phenytoin is in Phase 1 clinical development. One Phase 1 trial has been completed. The drug is investigational and has not been approved by the FDA for any indication.
Extended Phenytoin has been studied in one completed Phase 1 trial, NCT00647621, titled "Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin® Kapseals® 100 mg." The trial enrolled 72 healthy adult volunteers in the United States and was active-controlled, randomized, and not double-blind.