None listed
Conditions
Brief summary
To compare the pharmacokinetics of three IPX231 formulations administered subcutaneously as well as a single IPX231 formulation (IPX231-L0007) administered sublingually by two different methods: instillation via syringe versus spray in healthy adults.
Interventions
IPX231 will be administered a single-center, open-label, randomized, single-dose, 4 sequence, 4 treatment crossover study. Treatments will be separated by at least a 7-day washout period. Subjects will remain at the clinical facility for approximately 24 hours during each of the 4 treatment periods.
Treatment A: IPX231-L0007 (solution) 0.25 mL administered sublingually via syringe.
Treatment B: IPX231-L0007 (solution) 0.25 mL administered sublingually via spray pump.
Treatment C: IPX231-C0001 (
IPX231 will be administered a single-center, open-label, randomized, single-dose, 4 sequence, 4 treatment crossover study. Treatments will be separated by at least a 7-day washout period. Subjects will remain at the clinical facility for approximately 24 hours during each of the 4 treatment periods. Treatment A: IPX231-L0007 (solution) 0.25 mL administered sublingually via syringe. Treatment B: IPX231-L0007 (solution) 0.25 mL administered sublingually via spray pump. Treatment C: IPX231-C0001 (encapsulated powder) 34.2 mg administered sublingually by dispersion of powder. Treatment D: Apomine Injection (0.2 mL of 10 mg apomorphine HCl/mL), containing 2.0 mg apomorphine HCl (1.76 mg apomorphine), administered subcutaneously per package insert instructions
Sponsors
Impax Laboratories, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy adult subjects between 18 years and 45 years of age inclusive at the time of informed consent.
Exclusion criteria
Presence of a clinically significant disorder, as determined by the Investigator, involving bleeding or hematologic or cardiovascular system abnormalities, acute infections, respiratory, renal, gastrointestinal, immunologic, hepatic, reproductive, endocrine, or neurologic system(s); or psychiatric disease; or oral trauma or disease.
Outcome results
None listed