Healthy
Conditions
Keywords
Comparative, bioavailability, of PCA, formulations
Brief summary
A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.
Interventions
DRUGPCA
Placebo tablet, once
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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 * 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCA derivate blood levels | 24 hours |
Countries
Israel
Outcome results
None listed