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OpenTrials
Completed

NCT Number: NCT00729729

Pharmacokinetic Study for PCA Derivate Formulations

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCA

Drug

Placebo tablet, once

Primary outcomes

  1. PCA derivate blood levels

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Phase 4, Three Way Cross-over, Pharmacokinetic Study for PCA Derivate Formulations in Healthy Subjects

Acronym: PCA 1

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 7, 2008
Registry last updated
Aug 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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