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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 being studied in healthy volunteers. It is a formulation of phenytoin sodium in 100 mg extended-release capsules. The drug is currently in Phase 1 clinical development, and the completed trial enrolled healthy adult participants to evaluate its steady-state characteristics.
Extended Phenytoin is being developed by Viatris Inc. (NASDAQ: VTRS). The company is conducting clinical research on this extended-release phenytoin sodium capsule formulation, which is currently in Phase 1 development.
Extended Phenytoin is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities.
Extended Phenytoin has one completed Phase 1 trial, NCT00647621, titled 'Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin® Kapseals® 100 mg.' This randomized, active-controlled study enrolled 72 healthy volunteers in the United States and was biomarker-selected.
Extended Phenytoin is a small molecule formulation of phenytoin sodium. Phenytoin is an anticonvulsant that stabilizes neuronal membranes by modulating sodium channels, though specific molecular targets for this extended-release formulation have not been detailed in the available clinical trial information.