Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paxil · 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...
Paxil is a small molecule drug being developed by Teva Pharmaceutical Industries Limited. It is currently in Phase 1 clinical trials, studied in healthy volunteers to assess the effects of paroxetine hydrochloride 40 mg tablets under fed and fasting conditions. It is not approved for any specific disease indication.
Paxil is developed by Teva Pharmaceutical Industries Limited, traded on the stock exchange under the ticker TEVA. The company is conducting Phase 1 clinical trials for this small molecule drug.
Paxil is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy volunteers.
Paxil has two completed Phase 1 clinical trials: NCT00841659, studying paroxetine hydrochloride 40 mg tablets under fed conditions with 24 participants, and NCT00841698, studying the same tablets under fasting conditions with 50 participants. Both trials were conducted in Canada with healthy volunteers aged 18 years and older.
Paxil is the brand name for the drug paroxetine hydrochloride. The clinical trials for Paxil specifically test paroxetine hydrochloride 40 mg tablets, indicating that Paxil and paroxetine hydrochloride refer to the same active pharmaceutical ingredient.