Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions

ClinicalTrials.gov ID: NCT01570959

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Official title

A Two Period, Two Treatment, Two Way, Steady State Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Fasting Conditions

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions.

Study identification

NCT ID: NCT01570959
Recruitment status: Completed
Study type: Interventional
Phase: Not applicable
Lead sponsor: Roxane Laboratories; Industry
Enrollment: 56 participants

Conditions and interventions

Conditions

Bipolar I Disorder

Interventions

Quetiapine Fumarate Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 2007 (Type not available)
Primary completion: Nov 2007 (Actual)
Completion: Nov 2007 (Actual)
Last update posted: Jan 23, 2018

2007

United States locations

U.S. sites: 7
U.S. states: 4
U.S. cities: 7

Facility	City	State	ZIP	Site status
Collaborative Neuroscience Network, Inc.	Garden Grove	California	92845	—
Synergy Clinical Research Center	National City	California	91950	—
Segal Institute for Clinical Research	North Miami	Florida	33161	—
Global Medical Institutes/Princeton Medical Institute	Princeton	New Jersey	08540	—
CRI Worldwide	Willingboro	New Jersey	08046	—
Community Clinical Research, Inc.	Austin	Texas	78754	—
Claghorn-Lesem Research Clinic, Ltd	Houston	Texas	77008	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01570959, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 23, 2018 · Synced Nov 15, 2026