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Study to Evaluate the Effect of Food Intake on the Plasma Concentration Changes of Quetiapine After Oral Administration of FK949E in Healthy Volunteers

NCT01871987 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-03-09

No results posted yet for this study

Summary

A study to evaluate the effect of food on the plasma concentration changes of quetiapine after oral administration of FK949E (extended release formulation of quetiapine) in healthy male subjects.

Conditions

  • Healthy
  • Plasma Concentration Change of Quetiapine

Interventions

DRUG

FK949E

oral

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
44 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Japan

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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 NCT01871987 on ClinicalTrials.gov