Status:
COMPLETED
Pharmacokinetic Study for PCA Derivate Formulations
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE4
Brief Summary
A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.
Eligibility Criteria
Inclusion
- Subjects who have completed the informed consent process culminating with written informed consent by the subject.
- 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
- Subjects who suffer from a current medical condition.
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00729729
Start Date
July 1 2008
End Date
December 1 2009
Last Update
August 28 2012
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120