Evaluation of the Pharmacokinetics of Sublingual IPX237 in Healthy Volunteers

Phase 1

Completed

• Conditions: Depression; Mental Health - Depression

• Registration Number: ACTRN12614000444684
• Lead Sponsor: Impax Pharmaceuticals,A Division of Impax Laboratories, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Healthy volunteers between the ages of 18 and 55 years of age inclusive, weighing at least 60 kg with BMI of 18.0 kg/m2 to 29.5 kg/m2 (inclusive) at the time of informed consent.

Exclusion Criteria

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, musculoskeletal, hematologic, dermatologic, hepatic, reproductive, endocrine, or neurologic/psychiatric, as determined by clinical investigators.
History of psychosis in self or family.
History of or clinical signs of glaucoma.
History of or clinical signs of any form of epilepsy or seizures

Study & Design

• Study Type: Interventional
• Study Design: Not specified