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NCT00239564 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

A Phase 1 study of Idiopathic Parkinson´s Disease, sponsored by Impax Laboratories.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target
2
Study locations

NCT00239564: Completed Phase 1 study of Idiopathic Parkinson´s Disease, sponsored by Impax Laboratories.

NCT00239564 is a Phase 1 study of Idiopathic Parkinson´s Disease that has completed, run by Impax Laboratories. The registered enrollment target is 12 participants, below the 218-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00239564, a Phase 1 study of Idiopathic Parkinson´s Disease, has completed, sponsored by Impax Laboratories.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target
2
Study locations

Study Summary

The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.

Interventions

  • DRUG IPX054 200 mg
  • DRUG IPX054 100 mg
  • DRUG IPX054 150 mg
  • DRUG IPX054 250 mg
  • DRUG IPX054 300 mg

Study Locations (2)

California

  • Site 101 - Sunnyvale

Kansas

  • Site 102 - Lawrence

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2005-10
Est. Completion 2007-12
Phase Phase 1
Impax Laboratories

19 total trials

What the finished NCT00239564 record still lists

NCT00239564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 218-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Idiopathic Parkinson´s Disease appearing as the primary indexed condition, and to 5 interventions - of which IPX054 200 mg is the first listed.

NCT00239564 reports a single indexed study location in California, Kansas.

Frequently Asked Questions

What is clinical trial NCT00239564 about?

NCT00239564 is a clinical study titled "Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease". The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.

What is the current status of trial NCT00239564?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2005-10. Estimated completion is 2007-12.

What conditions does trial NCT00239564 study?

This clinical trial studies the following conditions: Idiopathic Parkinson´s Disease.

What interventions are being tested in trial NCT00239564?

The interventions under investigation include: IPX054 200 mg (DRUG), IPX054 100 mg (DRUG), IPX054 150 mg (DRUG), IPX054 250 mg (DRUG), IPX054 300 mg (DRUG).

Who is sponsoring clinical trial NCT00239564?

This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00239564 being conducted?

This trial has 2 study locations across California, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00239564, the US trial registry maintained by the National Library of Medicine. NCT00239564 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.