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Study Evaluating Effects of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG in Healthy Subjects

NCT00519298 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2008-04-22

No results posted yet for this study

Summary

Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in healthy subjects.

Conditions

  • Healthy
  • Adult

Interventions

DRUG

SAM-531

dosage form : 0.5 mg and 5 mg capsules 3 different single doses : 1 mg, 3mg and 10 mg of SAM-531

OTHER

placebo

placebo

DRUG

Donepezil

dosage form: 5 mg encapsulated tablets one single dose of 5 mg.

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

  • Trial Manager · For France: [email protected]

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • France

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 NCT00519298 on ClinicalTrials.gov