Evaluation of the Pharmacokinetics of IPX231 (L0007, C0001) in Healthy Subjects

Completed

• Conditions: Parkinson's disease; Neurological - Parkinson's disease

• Registration Number: ACTRN12613000973718
• Lead Sponsor: Impax Laboratories, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Healthy adult subjects between 18 years and 45 years of age inclusive at the time of informed consent.

Exclusion Criteria

Presence of a clinically significant disorder, as determined by the Investigator, involving bleeding or hematologic or cardiovascular system abnormalities, acute infections, respiratory, renal, gastrointestinal, immunologic, hepatic, reproductive, endocrine, or neurologic system(s); or psychiatric disease; or oral trauma or disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics[During each treatment period, blood samples will be obtained within 1 hour predose, and at 5, 10, 20, 30, 40, 50 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose.]

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs), three serial 12-lead electrocardiograms (ECG), telemetry, physical exams, clinical laboratory test data, vital signs, and concomitant medications will be collected and evaluated over the course of the study.<br><br>AEs associated with IPX231 are expected to be similar to Apomine which include nausea, vomiting, drowsiness, somnolence, muscle pain and feeling faint.<br><br>AEs associated with Motilium include dry mouth, headache, nervousness, diarrhoea, nausea, heart burn, constipation and appetite disorders.<br>[Throughout the course of the study.]