Pharmacokinetic Study for PCA Derivate Formulations (PCA 1)

August 27, 2012 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo
Drug: PCA
Placebo tablet, once
Drug: PCA
PO, 700mg, once
Drug: PCA
PO, 1000mg, once
Experimental: 2
Slow release PCA derivative
Drug: PCA
Placebo tablet, once
Drug: PCA
PO, 700mg, once
Drug: PCA
PO, 1000mg, once
Experimental: 3
Slow release PCA derivative higher dose
Drug: PCA
Placebo tablet, once
Drug: PCA
PO, 700mg, once
Drug: PCA
PO, 1000mg, once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PCA derivate blood levels
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 3, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (Estimate)

August 7, 2008

Study Record Updates

Last Update Posted (Estimate)

August 28, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PCA pharmacokinetics 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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