This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder
Alkermes Investigator Site
Las Vegas, Nevada, United States
Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48)
Time frame: Up to 15 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Up to 15 days
Area under the concentration-time curve from time zero to infinity (AUC∞)
Time frame: Up to 15 days
\Maximum observed concentration (Cmax)
Time frame: Up to 15 days
Time to reach Cmax (tmax)
Time frame: Up to 15 days
Terminal half-life (t½)
Time frame: Up to 15 days
Total amount of drug excreted in milk (milligrams)
Time frame: Up to 15 days
Relative drug excreted in milk to dose percentage
Time frame: Up to 15 days
Estimated infant dose (mg/kg)
Time frame: Up to 15 days
Estimated relative infant dose to the weight-adjusted maternal dose (%)
Time frame: Up to 15 days
Incidence of adverse events
Time frame: Up to 15 days
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