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A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Experimental | Slow release PCA derivative |
|
| 3 | Experimental | Slow release PCA derivative higher dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCA | Drug | Placebo tablet, once |
| |
| PCA |
| Measure | Description | Time Frame |
|---|---|---|
| PCA derivate blood levels | 24 hours |
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Inclusion Criteria:
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
Normal physical examination
Within +/- 10% of normal values in laboratory examinations
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Jerusalem | 91120 | Israel |
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| ID | Term |
|---|---|
| D010323 | Passive Cutaneous Anaphylaxis |
| ID | Term |
|---|---|
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Drug |
PO, 700mg, once |
|
| PCA | Drug | PO, 1000mg, once |
|
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |