NCT00835575

15 mg Mirtazapine Orally Disintegrating Tablets, Fasting

A Relative Bioavailability Study of 15 mg Mirtazapine Orally Disintegrating Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Mirtazapine 15 mg (Orally Disintegrating) Tablets	1 x 15 mg, single-dose fasting
DRUG	REMERON SolTab® 15 mg Orally Disintegrating Tablets	1 x 15 mg, single-dose fasting

Timeline

• Start date: 2003-07-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2009-02-03
• Last updated: 2024-08-20
• Results posted: 2009-08-18

Locations

1 site across 1 country: United States