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Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fasting Condition

NCT01603173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-05-22

No results posted yet for this study

Summary

This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects.

Conditions

  • Fasting State

Interventions

DRUG

Quetiapine Fumarate Tablets 25 mg

25 mg tablet once a day

DRUG

Quetiapine Fumarate

25 mg tablet once a day

Sponsors & Collaborators

  • IPCA Laboratories Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Nirav Gandhi, M.D. · Accutest Research Lab (I) Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-11-30
Completion
2011-11-30

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 NCT01603173 on ClinicalTrials.gov