Pharmacokinetic Study for PCA Derivate Formulations (PCA 1)

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00729729
First received: August 3, 2008
Last updated: August 27, 2012
Last verified: August 2008
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729729

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

No publications provided

Responsible Party: Gadi Lalazar MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00729729     History of Changes
Other Study ID Numbers: PCA pharmacokinetics 1
Study First Received: August 3, 2008
Last Updated: August 27, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on April 22, 2014