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Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions

NCT01570907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-01-23

No results posted yet for this study

Summary

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fasted conditions.

Conditions

  • Treatment for Bipolar I Disorder

Interventions

DRUG

Quetiapine Fumarate

25 mg tablet

Sponsors & Collaborators

  • Roxane Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2007-07-31
Completion
2007-07-31

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 NCT01570907 on ClinicalTrials.gov