Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paxil · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Paroxetine hydrochloride 40 mg tablet |
| 2 | ACTIVE_COMPARATOR | Paxil® 40 mg Tablet |
| Name | Type | Description |
|---|---|---|
| Paroxetine hydrochloride 40 mg tablet | DRUG | 40mg, single dose fed |
| Paxil® 40 mg Tablet | DRUG | 40mg, single dose fed |
| Paroxetine Hydrochloride Controlled-Release Tablets 25 mg | DRUG | 25mg, single dose fed |
| Paxil CR™ Tablets 25 mg | DRUG | 25mg, single dose fed |
Inclusion Criteria: 1. Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing. 2. Subjects who completed the screening process within 21 days prior to Period I dosing. 3. Subjects who were healthy adult men a...
Paxil is an investigational small molecule being studied in healthy volunteers. The drug is in Phase 1 clinical development, with completed trials evaluating paroxetine hydrochloride formulations, including controlled-release 25 mg tablets and 40 mg tablets, compared to reference Paxil CR and Paxil products.
Paxil is being developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. The drug is currently in Phase 1 clinical development, with trials conducted in the United States.
Paxil is in Phase 1 clinical development. All three clinical trials listed for the drug are completed, with no active trials currently ongoing. The drug is investigational and has not been approved for any indication.
Paxil has three completed Phase 1 clinical trials: NCT00647881, a food study of paroxetine hydrochloride controlled-release 25 mg tablets versus Paxil CR 25 mg; NCT00648427, a fasting study of the same formulations; and NCT00650403, a food study of paroxetine hydrochloride 40 mg tablets versus Paxil 40 mg. All trials enrolled healthy adults in the United States.
Paxil is a brand name for paroxetine hydrochloride, a small molecule drug. The clinical trials listed for Paxil compare generic paroxetine hydrochloride formulations to the reference products Paxil CR and Paxil, indicating that Paxil refers to the branded paroxetine products.