Evaluation of the Pharmacokinetics of IPX233 Formulations in Healthy Volunteers
IPX233-B13-01:Evaluation of the Pharmacokinetics of IPX233 Formulations in Healthy Volunteers
Impax Pharmaceuticals,A Division of Impax Laboratories, Inc.
20 participants
Dec 6, 2013
Interventional
Conditions
Summary
To characterize the pharmacokinetics (PK) of three IPX233 formulations (C0001, C0002, T0001) compared with one IPX233 formulation (T0002).
Eligibility
Inclusion Criteria1
- Healthy volunteers between the ages of 18 and 55 years of age (inclusive) at the time of informed consent.
Exclusion Criteria4
- 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.
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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 (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
Locations(1)
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ACTRN12613001073796