NCT00729729

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Jul 2008

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 28, 2012

Status Verified

August 1, 2008

Enrollment Period

7 months

First QC Date

August 3, 2008

Last Update Submit

August 27, 2012

Conditions

Healthy

Keywords

Comparativebioavailabilityof PCAformulations

Outcome Measures

Primary Outcomes (1)

  • PCA derivate blood levels

    24 hours

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo

Drug: PCA

2

EXPERIMENTAL

Slow release PCA derivative

Drug: PCA

3

EXPERIMENTAL

Slow release PCA derivative higher dose

Drug: PCA

Interventions

PCADRUG

Placebo tablet, once

1

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Interventions

Passive Cutaneous Anaphylaxis

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesAntigen-Antibody ReactionsImmune System Phenomena

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2008

First Posted

August 7, 2008

Study Start

July 1, 2008

Primary Completion

February 1, 2009

Study Completion

December 1, 2009

Last Updated

August 28, 2012

Record last verified: 2008-08

Locations

IL(1)