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Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.
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Volunteers
Inclusion criteria
Age 18-55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the first screening visit.
Willingness to comply with any applicable contraceptive requirements fo the protocol and is:
Must be considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, and urinalysis.
An understanding, ability, and willingness to fully comply with study procedures and restrictions
Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with International Conference on harmonisation Good Clinical Practice Guideline E6 (1996) and applicable regulations, before completing any study related procedures
A body mass index between 18.5-30.0kg/m² inclusive. This inclusion criterion will only be assessed at the first screening visit.
A hemoglobin value of >=12.0g/dL at the Screening Visit and on Day -1 of Treatment Period 1.
Ability to swallow a dose of investigational product according to the study conditions.
Exclusion criteria
Subjects are excluded from the study if any of the following criteria are met at the Screening Visit or at Day 1 of Treatment Period 1 (if reassessed):
Primary purpose
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Interventional model
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30 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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