NCT00865696

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

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

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

Summary

The purpose of this study is to compare the relative bioavailability of 15 mg Mirtazapine Tablets by Purepac Pharmaceutical Co with that of 15 mg REMERON® Tablets by Organon Inc. following a single oral dose (1 x 15 mg) in healthy adult volunteers under fasting conditions.

Detailed description

Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study under fasting conditions Official Title: A Relative Bioavailability of 15 mg Mirtazapine Tablets Under Fasting Conditions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Mirtazapine 15 mg tablets, single dose	A: Experimental Subjects received Purepac formulated products under fasting conditions
DRUG	REMERON® 15 mg tablets, single dose	B: Active comparator Subjects received Organon Inc. formulated products under fasting conditions

Timeline

• Start date: 2001-09-01
• Primary completion: 2001-09-01
• Completion: 2001-09-01
• First posted: 2009-03-19
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States