Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Modafinil · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Modafinil Tablets 200 mg |
| 2 | ACTIVE_COMPARATOR | Provigil® Tablets 200 mg |
| Name | Type | Description |
|---|---|---|
| Modafinil Tablets 200 mg | DRUG | 200mg, single dose fasting |
| Provigil® Tablets 200 mg | DRUG | 200mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administratio...
Modafinil is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being evaluated in pharmacokinetic studies to assess how it is absorbed and processed by the body under fasting and fed conditions.
Modafinil is being developed by Viatris Inc., a company traded on the NASDAQ under the ticker VTRS. Viatris is conducting clinical trials to evaluate the drug's pharmacokinetic profile in healthy adult participants.
Modafinil is in Phase 1 clinical development. Two Phase 1 studies have been completed, both involving healthy volunteers. The drug is investigational and has not been approved for any indication.
Modafinil has been studied in two completed Phase 1 trials. NCT00650000 was a fasting study comparing Modafinil tablets 200 mg to Provigil tablets 200 mg in 32 participants. NCT00650286 was a food study comparing the same doses in 20 participants. Both trials were conducted in the United States.
Modafinil is being studied as a generic version of Provigil. The clinical trials compared Modafinil tablets 200 mg directly to Provigil tablets 200 mg to evaluate bioequivalence under fasting and fed conditions. Both drugs contain the same active ingredient, modafinil.