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NCT03007888 · ClinicalTrials.gov registry record · Phase 2

A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

A Phase 2 study, sponsored by Impax Laboratories.

Completed
Registry status
Phase 2
Development phase
28
Enrollment target

NCT03007888 is a Phase 2 study that has completed, run by Impax Laboratories. The registered enrollment target is 28 participants.

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The verdict

NCT03007888, a Phase 2 study, has completed, sponsored by Impax Laboratories.

COMPLETED
Registry status
Phase 2
Development phase
28 participants
Enrollment target

Study Summary

Primary Objective: To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD). Secondary Objectives: To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD. To compare the efficacy of IPX203 with IR CD-LD following multiple doses. To evaluate the safety of IPX203.

Interventions

  • DRUG Sinemet
  • DRUG IPX203

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2016-11-14
Est. Completion 2017-08-01
Phase Phase 2

Sponsor

Impax Laboratories

19 total trials

What the Registry Record Tells You About NCT03007888

The ClinicalTrials.gov registry entry for NCT03007888 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Impax Laboratories, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Sinemet is the first listed.

NCT03007888 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03007888 about?

NCT03007888 is a clinical study titled "A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease". Primary Objective: To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD). Secondary Objectives: To compare the pharmacodynamics of single and multiple doses of IPX203 with...

What is the current status of trial NCT03007888?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2016-11-14. Estimated completion is 2017-08-01.

What interventions are being tested in trial NCT03007888?

The interventions under investigation include: Sinemet (DRUG), IPX203 (DRUG).

Who is sponsoring clinical trial NCT03007888?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.