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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
  Purpose
A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.

Condition Intervention Phase
Healthy Drug: PCA Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Phase 4, Three Way Cross-over, Pharmacokinetic Study for PCA Derivate Formulations in Healthy Subjects

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • PCA derivate blood levels [ Time Frame: 24 hours ]

Estimated Enrollment: 30
Study Start Date: July 2008
Study Completion Date: December 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: PCA
Placebo tablet, once
Experimental: 2
Slow release PCA derivative
Drug: PCA
PO, 700mg, once
Experimental: 3
Slow release PCA derivative higher dose
Drug: PCA
PO, 1000mg, once

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729729


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: Gadi Lalazar MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00729729     History of Changes
Other Study ID Numbers: PCA pharmacokinetics 1
First Submitted: August 3, 2008
First Posted: August 7, 2008
Last Update Posted: August 28, 2012
Last Verified: August 2008

Keywords provided by Hadassah Medical Organization:
Comparative
bioavailability
of PCA
formulations