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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014