Evaluation of the Pharmacokinetics of IPX233 Formulations in Healthy Volunteers
Phase 1
Completed
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)Neurological - Other neurological disorders
- Registration Number
- ACTRN12613001073796
- Lead Sponsor
- Impax Pharmaceuticals,A Division of Impax Laboratories, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Healthy volunteers between the ages of 18 and 55 years of age (inclusive) at the time of informed consent.
Exclusion Criteria
Any history of drug or alcohol addiction or abuse within the last 5 years.
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, immunologic, hematologic, dermatologic, hepatic, reproductive, endocrine, or neurologic/psychiatric, as determined by clinical investigators.
History of or clinical signs of 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
- Primary Outcome Measures
Name Time Method Pharmacokinetics [A total of 15 blood samples (6 mL each) will be collected at the following timepoints after administration of IPX233 in each treatment period to quantify IPX233 and potential metabolites in plasma: Predose (up to 60 minutes prior to dosing), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose.<br>]
- Secondary Outcome Measures
Name Time Method Safety[12-lead electrocardiogram (ECGs), clinical laboratory tests, vital signs, adverse events (AEs), and concomitant medications will be evaluated over the course of the study. Physical examinations will be performed at Screening and at Study Exit. ECGs will be evaluated prior to the administration of IPX233 and after dosing in each treatment period. <br>Postdose:<br>Measure BP (blood pressure), HR(heart rate) and RR(respiratory rate) at approximately 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours after dosing in each treatment period (subject should be supine for at least 5 minutes prior to measurements)<br>Conduct 12-lead ECG at approximately 2, 6 and 24 hours postdosing in each treatment period<br><br>The possible adverse events (e.g. dry mouth, insomnia, constipation, etc.)]