Pharmacokinetic Study for PCA Derivate Formulations

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: PCA

• Registration Number: NCT00729729
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Status Verified: 2008-08
• Study First Submitted: 2008-08-03
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-07
• Primary Completion: 2009-02
• Study Completion: 2009-12
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	PCA	Placebo
2	PCA	Slow release PCA derivative
3	PCA	Slow release PCA derivative higher dose

Primary Outcome Measures

Name	Time	Method
PCA derivate blood levels	24 hours

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel