WithdrawnPhase 1ACTRN12614000518662

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

IPX233-B14-02: Evaluation of the pharmacokinetics and safety of multiple once-daily doses of IPX233 in healthy adult volunteers

Sponsor

Impax Laboratories, Inc

Enrollment

20 participants

Start Date

Aug 4, 2014

Study Type

Interventional

Conditions

Attention Deficit Hyperactivity Disorder (ADHA)

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria1

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

Exclusion Criteria4

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.

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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

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.

Locations(1)

SA, Australia

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ACTRN12614000518662