Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Venlafaxine Hydrochloride
Venlafaxine · 5 trials · 1 indication
Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).
Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Venlafaxine Hydrochloride 150 mg Extended-Release Capsules. |
| Reference Listed Drug | ACTIVE_COMPARATOR | Effexor® XR 150 mg Extended-Release Capsules |
| Venlafaxine | EXPERIMENTAL | Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period |
| Effexor® | ACTIVE_COMPARATOR | Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Venlafaxine Hydrochloride | DRUG | 150 mg Extended-Release Capsule |
| Effexor® XR | DRUG | 150 mg Extended-Release Capsule |
| Venlafaxine 25 mg Tablets | DRUG | 1 x 25 mg, single-dose fasting |
| Effexor® 25 mg Tablets | DRUG | 1 x 25 mg, single-dose fasting |
Inclusion Criteria: * Members of the community at large. * Subjects will be females and/or males, non-smokers, 18 years of age and older. * Female subjects will be postmenopausal or surgically sterilized. Exclusion Criteria: * Clinically significant illness within 4 weeks of the administration of...