Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2010-11-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NPC-09
Period 1: NPC-09 800mg single oral dosing NPC-09 800mg three times oral dosing a day Period 2: NPC-09 800mg three times oral dosing a day for 5 consecutive days
NPC-09
NPC-09 tablet NPC-09 contains 50mg or 100mg N-acetylneuraminic acid (anhydride)
Interventions
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NPC-09
NPC-09 tablet NPC-09 contains 50mg or 100mg N-acetylneuraminic acid (anhydride)
Eligibility Criteria
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Inclusion Criteria
* No severe complications when informed consent is obtained
* More than 40 kg in weight before administration
Exclusion Criteria
* Presence or history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, metabolic, gastrointestinal, brain, psychiatric, neurologic disease
* Intake of supplement contains sialic acid, St. John's wort or grapefruit within 7 days
* Enrollment in another investigational study within 3 months
* More than 400 mL blood donation within 3 months
* Presence of alcohol or drug dependency
* Women who are pregnant , breast feeding or possible to be pregnant.
* Patients whom the investigator judges not to be appropriate for the subject
20 Years
40 Years
ALL
No
Sponsors
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Tohoku University
OTHER
Responsible Party
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Tohoku University Hospital Internal Neurology
Principal Investigators
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Masashi Aoki
Role: PRINCIPAL_INVESTIGATOR
Tohoku University Hospital Internal Neurology
Locations
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Tohoku University Hospital
Sendai, Miyagi, Japan
Countries
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Other Identifiers
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Sialic acid-1
Identifier Type: -
Identifier Source: org_study_id
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