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Bioequivalence Study of Quetiapine Fumarate Tablets 300 mg Under Fasting Condition

NCT01566487 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-03-29

No results posted yet for this study

Summary

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, multicentric experimental bioequivalence study.

Conditions

  • Healthy

Interventions

DRUG

Quetiapine fumarate

Quetiapine fumarate tablets 300mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr.Sachin Patkar, MD · Masina hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • India

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 NCT01566487 on ClinicalTrials.gov