Evaluation of the pharmacokinetics and safety of multiple once-daily doses of IPX233 in healthy adult volunteers

Phase 1

Withdrawn

• Conditions: Attention Deficit Hyperactivity Disorder (ADHA); Neurological - Other neurological disorders; Mental Health - Other mental health disorders

• Registration Number: ACTRN12614000518662
• Lead Sponsor: Impax Laboratories, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn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

Inclusion Criteria

Healthy volunteers between the ages of 18 and 45 years of age (inclusive) at the time of informed consent.

Exclusion Criteria

Any history of drug or alcohol addiction or abuse.
Presence of a clinically significant disorder including acute or chronic infections, or a malignant neoplasm, and/or involving disease in one or more of these organ systems: cardiovascular, respiratory, renal, gastrointestinal, musculoskeletal, immunologic, hematologic, dermatologic, hepatic, reproductive, endocrine, neurologic, or psychiatric (including bipolar disorder), as determined by Clinical Investigators.
History of or clinical signs of narrow angle glaucoma, benign prostatic hypertrophy or urinary retention.
History of or clinical signs of any form of epilepsy or seizures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified