CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Mirtazapine 15 mg (Orally Disintegrating) Tablets +1 moredrug
Likely dose
Mirtazapine 15 mg (Orally Disintegrating) Tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00835575
NCT00835575Phase 1Completed
CompareCT.gov

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

Teva Pharmaceuticals USA·interventional·Posted Feb 3, 2009·Updated Aug 20, 2024

In Brief

A Phase 1 clinical trial evaluating Mirtazapine 15 mg (Orally Disintegrating) Tablets and REMERON SolTab® 15 mg Orally Disintegrating Tablets for Healthy. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 3, 2009
Enrollment StartJul 1, 2003
Primary CompletionAug 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago

Interventions

Mirtazapine 15 mg (Orally Disintegrating) Tabletsdrug

1 x 15 mg, single-dose fasting

REMERON SolTab® 15 mg Orally Disintegrating Tabletsdrug

1 x 15 mg, single-dose fasting