15 mg Mirtazapine Orally Disintegrating Tablets, Non-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 non-fasting conditions.

Timeline

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

Outcome

Met primary endpoint

registry analysis (unspecified test); Test (Mirtazapine) vs Reference (Remeron®); Ratio of the T/R geometric mean x 100 100.59 (90% CI 95.76 to 105.65) NCT00834197 ↗

registry analysis (unspecified test); Test (Mirtazapine) vs Reference (Remeron®); Ratio of the T/R geometric mean x 100 98.17 (90% CI 94.82 to 101.65) NCT00834197 ↗

registry analysis (unspecified test); Test (Mirtazapine) vs Reference (Remeron®); Ratio of the T/R geometric mean x 100 98.25 (90% CI 95.22 to 101.39) NCT00834197 ↗

Drugs

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

Indications

No indication recorded.