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
PHASE4
30 participants
INTERVENTIONAL
2008-07-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
QUADRUPLE
Study Groups
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1
Placebo
PCA
Placebo tablet, once
2
Slow release PCA derivative
PCA
PO, 700mg, once
3
Slow release PCA derivative higher dose
PCA
PO, 1000mg, once
Interventions
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PCA
Placebo tablet, once
PCA
PO, 700mg, once
PCA
PO, 1000mg, once
Eligibility Criteria
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Inclusion Criteria
* Males
* Age 18-45 years
* Abstinence from alcohol for 1 week prior to the study
* Non smoking
* BMI \> 19 and \< 30
* No history or evidence of significant
* cardiovascular,
* hepatic,
* renal,
* hematopoietic,
* gastrointestinal disease,
* endocrine,
* metabolic,
* psychiatric
* psychological disorders
* Normal physical examination
* Within +/- 10% of normal values in laboratory examinations
Exclusion Criteria
* Subjects who smoke.
* Subjects who drink \> 20 grams of alcohol per day.
* Subjects who take prescription medication.
* Subjects with an abnormality in screening blood tests
* Known sensitivity to any ingredients in the study drug
18 Years
45 Years
MALE
Yes
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Hadassah Medical Organization
Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Other Identifiers
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PCA pharmacokinetics 1
Identifier Type: -
Identifier Source: org_study_id