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COMPLETED Phase 1

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

NCT00239564 · View on ClinicalTrials.gov ↗

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

Sponsor

Impax Laboratories

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00239564

The ClinicalTrials.gov registry entry for NCT00239564 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Impax Laboratories, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00239564 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00239564?

This trial is sponsored by Impax Laboratories, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial