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Paroxetine Controlled-Release · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Paroxetine Hydrochloride Controlled-Release Tablets 25 mg |
| 2 | ACTIVE_COMPARATOR | Paxil CR™ Tablets 25 mg |
| Name | Type | Description |
|---|---|---|
| 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. 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 (Beta HCG) pregnancy test performed within 14 days prior to the start of the study and on the evening prior to each dose administ...
Paroxetine controlled-release is a small molecule formulation of paroxetine hydrochloride supplied as controlled-release tablets of 25 mg. It is being developed by Viatris Inc., which trades under the ticker VTRS. The program is in Phase 1 clinical development, and the specific indications being pursued have not been disclosed.
Paroxetine controlled-release targets SLC6A4, the serotonin transporter. It acts as an inhibitor of this target. SLC6A4 is the protein responsible for reuptake of serotonin from the synaptic space, and inhibition of it is the established mechanism associated with this class of small molecule compounds.
Viatris Inc., which trades on the Nasdaq under the ticker VTRS, is the developer of paroxetine controlled-release. The company is responsible for the clinical development program for paroxetine hydrochloride controlled-release tablets 25 mg.
Paroxetine controlled-release is in Phase 1 clinical development. It is an investigational product and is not approved. Two Phase 1 trials have been completed, and no trials are currently active. The program has enrolled a total of 150 participants across those completed studies.
Two completed Phase 1 trials have evaluated paroxetine controlled-release: NCT00648427, a fasting study comparing paroxetine hydrochloride controlled-release tablets 25 mg with Paxil CR tablets 25 mg, and NCT00647881, a food study with the same comparison. Both enrolled 75 healthy volunteers in the United States and used an active-controlled design.