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AssigneeLipocine Inc.
InventorsKilyoung Kim, Mahesh V. Patel, Nachiappan Chidambaram, Satish K. Nachaegari, Burke Byrne, Jonathan A. Baker
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Disclosed are pharmaceutical compositions and oral dosage forms including capsules containing (17-ß)-3-oxoandrost-4-en-17-yl tridecanoate, and related methods. The capsule fill can include an additive and about 14 wt % to about 42 wt % for androst-4-en-17β-ol-3-one esters that comprise (17-ß)-3-oxoandrost-4-en-17-yl tridecanoate or a combination of (17-ß)-3-oxoandrost-4-en-17-yl undecanoate, (17-ß)-3-oxoandrost-4-en-17-yl dodecanoate, and (17-ß)-3-oxoandrost-4-en-17-yl tridecanoate. A single oral administration to a male subject of one or more dosage forms with a total androst-4-en-17β-ol-3-one equivalent dose of about 150 mg to about 895 mg is provided. In another embodiment, a method for providing a serum concentration of androst-4-en-17β-ol-3-one within a target PK performance for a male subject is provided. In a further embodiment, the pharmaceutical compositions and methods comprising androst-4-en-17β-ol-3-one ester loading of 14 wt % to 42 wt % achieve androst-4-en-17β-ol-3-one PK performance targets and require titration(s) to show therapeutic effectiveness for treatment of hypogonadism.
A method of administering a treatment regimen for at least one condition associated with at least one of fatty liver, NAFLD, alcoholic fatty liver disease, viral fatty liver disease, genetic fatty liver disease, hepatitis, alcoholic steatohepatitis, viral steatohepatitis, genetic steatohepatitis, hepatic encephalopathy (HE), hepatocellular ballooning, NASH, cirrhosis, NASH with cirrhosis, NASH with fibrosis, post-liver-transplantation, pending liver transplantation, liver transplantation rejection, and an abnormal level of at least one liver disease related biomarker (LDRB) comprising at least one of ALP, ALT, AST, GGT, triglycerides, LDL, cholesterol, liver biopsy, inflammation biomarkers, non-HDL cholesterol, hematocrit, hemoglobin, lipoprotein phospholipase A2, bilirubin, albumin, and SHBG, said method comprising:
Dependencies are inferred from the claim text.