Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01282814 | Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study | PHASE1 | COMPLETED | 24 | — | — | Feb 1, 2003 | Mar 1, 2003 | Mar 8, 2011 | 1 | Canada |
| NCT00834249 | Venlafaxine 25 mg Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 18 | — | — | Dec 1, 2002 | Dec 1, 2002 | Aug 19, 2024 | 2 | Canada |
| NCT00834964 | Venlafaxine 25 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 30 | — | — | Dec 1, 2002 | Dec 1, 2002 | Aug 19, 2024 | 2 | Canada |
| NCT01260896 | Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Sep 1, 2002 | Oct 1, 2002 | Feb 21, 2011 | 1 | Canada |
| NCT01282801 | Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fed Conditions | PHASE1 | COMPLETED | 18 | — | — | Sep 1, 2002 | Oct 1, 2002 | Mar 8, 2011 | 1 | Canada |
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...