None listed
Conditions
Brief summary
To characterize the pharmacokinetics (PK) of three IPX233 formulations (C0001, C0002, T0001) compared with one IPX233 formulation (T0002).
Interventions
An open-label, randomized, 4-sequence, 4-treatment, single-dose crossover study with at least 7 days of washout between each treatment period.
Treatment A: 1 capsule of IPX233-C0001 2 mg
Treatment B: 1 capsule of IPX233-C0002 2 mg
Treatment C: 1 tablet of IPX233-T0001 2 mg
Treatment D: 1 tablet of IPX233-T0002 2 mg
Postdose:
Measure BP (blood pressure), HR(heart rate) and RR(respiratory rate) at approximately 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours after dosing in each treatment period (s
An open-label, randomized, 4-sequence, 4-treatment, single-dose crossover study with at least 7 days of washout between each treatment period. Treatment A: 1 capsule of IPX233-C0001 2 mg Treatment B: 1 capsule of IPX233-C0002 2 mg Treatment C: 1 tablet of IPX233-T0001 2 mg Treatment D: 1 tablet of IPX233-T0002 2 mg Postdose: Measure BP (blood pressure), HR(heart rate) and RR(respiratory rate) at approximately 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours after dosing in each treatment period (subject should be supine for at least 5 minutes prior to measurements) Conduct 12-lead ECG at approximately 2, 6 and 24 hours postdosing in each treatment period
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) at the time of informed consent.
Exclusion criteria
Any history of drug or alcohol addiction or abuse within the last 5 years. 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 or clinical signs of glaucoma, benign prostatic hypertrophy or urinary retention. History of or clinical signs of any form of epilepsy or seizures.
Outcome results
None listed