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Pharmacokinetic Study for PCA Derivate Formulations (PCA 1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729729
First Posted: August 7, 2008
Last Update Posted: August 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
August 3, 2008
August 7, 2008
August 28, 2012
July 2008
February 2009   (Final data collection date for primary outcome measure)
PCA derivate blood levels [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT00729729 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetic Study for PCA Derivate Formulations
Phase 4, Three Way Cross-over, Pharmacokinetic Study for PCA Derivate Formulations in Healthy Subjects
A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Healthy
  • Drug: PCA
    Placebo tablet, once
  • Drug: PCA
    PO, 700mg, once
  • Drug: PCA
    PO, 1000mg, once
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: PCA
  • Experimental: 2
    Slow release PCA derivative
    Intervention: Drug: PCA
  • Experimental: 3
    Slow release PCA derivative higher dose
    Intervention: Drug: PCA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00729729
PCA pharmacokinetics 1
Yes
Not Provided
Not Provided
Gadi Lalazar MD, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP