None listed
Conditions
Brief summary
Study IPX233-B14-02 will evaluate the placebo-controlled safety and the PK of repeated once-daily doses of a 4 mg dose of an ER formulation of IPX233 in healthy adults.
Interventions
A single-blind, placebo-controlled, fixed-sequence study.
Subjects will remain housed in the study center through the first 14 nights and receive the following treatments orally with approximately 240 mL of room-temperature water in a fixed sequence:
Days 1-2: One placebo capsule once-daily taken immediately before a standard breakfast.
Day 3:One IPX233 ER C0003 capsule 4 mg taken immediately before a standard breakfast.
Day 4:One placebo capsule taken immediately before a standard breakfast.
A single-blind, placebo-controlled, fixed-sequence study. Subjects will remain housed in the study center through the first 14 nights and receive the following treatments orally with approximately 240 mL of room-temperature water in a fixed sequence: Days 1-2: One placebo capsule once-daily taken immediately before a standard breakfast. Day 3:One IPX233 ER C0003 capsule 4 mg taken immediately before a standard breakfast. Day 4:One placebo capsule taken immediately before a standard breakfast. Days 5-6-7-8-9-10-11:One IPX233 ER C0003 capsule 4 mg once-daily taken immediately before a standard breakfast. Days 12-13:One placebo capsule once-daily taken immediately before a standard breakfast.
Sponsors
Impax Laboratories, Inc
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Outcome results
None listed