drugset / Trial / NCT01282814

Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study

NCT01282814 ↗

Phase 1 Completed 24 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-label

Summary

The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg capsules (test) versus Effexor® XR (reference) administered as the content of 1 x 150 mg extended-release capsule mixed with applesauce under fasting conditions.

Timeline

Start
2003-02
Primary completion
2003-03
Completion
2003-03

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 115.85 (90% CI 108.45 to 123.72) NCT01282814 ↗

registry Ratio of the T/R geometric mean x 100 109.97 (90% CI 103.68 to 116.63) NCT01282814 ↗

registry Ratio of the T/R geometric mean x 100 106.46 (90% CI 101.45 to 111.71) NCT01282814 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Venlafaxine Small molecule 150 mg —

Indications

No indication recorded.