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

NCT00865696 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-08-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • James D. Carlson,, Pharm.D, · PRACS Institute, Ltd.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2001-09-30
Completion
2001-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00865696 on ClinicalTrials.gov