Pharmacokinetic Study for PCA Derivate Formulations

Healthy Clinical Trial

— PCA 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729729
• Other study ID #: PCA pharmacokinetics 1
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2008
• Last updated: August 27, 2012
• Start date: July 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PCA
Placebo tablet, once
• PCA
PO, 700mg, once
• PCA
PO, 1000mg, once

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCA derivate blood levels		24 hours	No