Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Paroxetine HCl
Paroxetine · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Paroxetine | EXPERIMENTAL | Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period |
| Paxil® | ACTIVE_COMPARATOR | Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Paroxetine HCl | DRUG | 40 mg Film-Coated Tablet |
| Paxil® | DRUG | 40 mg Film-Coated Tablet |
Inclusion Criteria * Subjects will be females and/or males, non-smokers, 18 years of age and older. * Female Subjects will be post-menopausal or surgically sterilized. * Post-menopausal status is defined as absence of menses for the past 12 months, * Sterile status is defined as hysterectomy, bilat...
Paroxetine is a small molecule drug candidate that Teva Pharmaceutical Industries Limited is developing. It is currently in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed.
Paroxetine targets SLC6A4, also known as the serotonin transporter. It acts as an inhibitor of this target. SLC6A4 is a protein involved in serotonin reuptake, and inhibiting it increases serotonin levels in the synaptic cleft.
Paroxetine is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. Teva is the sponsor of the clinical trials evaluating this drug candidate.
Paroxetine is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The two completed trials were Phase 1 studies conducted in healthy volunteers.
Paroxetine has been evaluated in two completed Phase 1 trials. NCT00841698 studied 40 mg tablets under fasting conditions in 50 healthy volunteers in Canada. NCT00841659 studied 40 mg tablets under fed conditions in 24 healthy volunteers in Canada. Both trials are completed.
Yes, Paroxetine HCl is another name for Paroxetine. Paroxetine HCl refers to the hydrochloride salt form of the drug. Both names refer to the same active pharmaceutical ingredient developed by Teva Pharmaceutical Industries Limited.