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...