Pharmacokinetics of IPX203

Completed

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

• Registration Number: ACTRN12613001057774
• Lead Sponsor: Impax Laboratories, Inc. Acting through its Impax Pharmaceuticals Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

Healthy males between 18 years and 65 years of age inclusive at the time of informed consent.

Exclusion Criteria

Presence of a clinically significant disorder involving bleeding or hematologic or cardiovascular system abnormalities, acute infections, respiratory, renal, gastrointestinal, immunologic, hepatic, reproductive, endocrine, or neurologic system(s), or psychiatric disease (as determined by the Investigator)
History of peptic ulcer disease or surgical procedure of the stomach, the small intestine, or the large intestine
History of glaucoma
Suspicious skin lesions or history of melanoma
History of neuroleptic malignant syndrome (NMS) or nontraumatic rhabdomyolysis
Subject has smoked or used tobacco products or nicotine products (patches, gums, etc.) within 60 days prior to Period 1 dosing; subjects does not agree to abstain from tobacco or nicotine products throughout the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified