None listed
Conditions
Brief summary
To characterize the pharmacokinetics (PK) of esketamine hydrochloride from 2 oral and 1 sublingual formulations of IPX237 compared to that from intravenous esketamine hydrochloride.
Interventions
An single-center, open-label, randomized, single-dose, 4-sequence, 4-treatment crossover study with at least 5 days of washout between dosing in each treatment period. Subjects will receive the following investigational treatments under fasted conditions in a randomized sequence: Treatment A: 1 capsule of IPX237-C0001 30 mg Treatment B: 1 capsule of IPX237-C0002 30 mg Treatment C: sublingual paste of IPX237-L0001 30 mg Treatment D: 15 mg esketamine (free base equivalent) infused IV over 40 minut
An single-center, open-label, randomized, single-dose, 4-sequence, 4-treatment crossover study with at least 5 days of washout between dosing in each treatment period. Subjects will receive the following investigational treatments under fasted conditions in a randomized sequence: Treatment A: 1 capsule of IPX237-C0001 30 mg Treatment B: 1 capsule of IPX237-C0002 30 mg Treatment C: sublingual paste of IPX237-L0001 30 mg Treatment D: 15 mg esketamine (free base equivalent) infused IV over 40 minutes Postdose: The subject should be evaluated at 32 hours postdose to determine that they are medically stable. The subject should be driven home by a responsible adult
Sponsors
Impax Pharmaceuticals, A Division of Impax Laboratories, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers between the ages of 18 and 55 years of age inclusive and weighing at least 60 kg 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, 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
Outcome results
None listed