15 mg Mirtazapine Orally Disintegrating Tablets, Fasting

Phase 1 Completed 32 enrolled Teva Pharmaceuticals USA

RandomizedCrossoverOpen-labelOther

Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc. following a single oral dose (1 x 15 mg) in healthy adult subjects under fasting conditions.

Timeline

Start: 2003-07
Primary completion: 2003-08
Completion: 2003-08

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 99.52 (90% CI 92.84 to 106.69) NCT00835575 ↗

registry Ratio of the T/R geometric mean x 100 103.59 (90% CI 99.13 to 108.25) NCT00835575 ↗

registry Ratio of the T/R geometric mean x 100 103.87 (90% CI 99.47 to 108.46) NCT00835575 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirtazapine	Other / unclassified	15 mg	Oral

Indications

No indication recorded.