SALT LAKE CITY, June 19, 2017 (GLOBE NEWSWIRE) — Lipocine Inc. (NASDAQ:LPCN), a specialty biologic company, today appear after-effects from both the Dosing Validation (‘DV’) and the Dosing Flexibility (‘DF’) studies evaluating ability and tolerability of LPCN 1021. LPCN 1021 is an articulate testosterone artefact applicant for testosterone backup assay (‘TRT’) in developed males for altitude associated with a absence of autogenous testosterone, additionally accepted as hypogonadism. The after-effects from these studies affirm the authority of a anchored dosage access after the charge for dosage titration to orally administering LPCN 1021.
LPCN 1021 auspiciously met the FDA primary ability guidelines in the DV abstraction area 81% of the capacity accomplished boilerplate testosterone levels (‘C’) aural the accustomed ambit with a lower apprenticed aplomb breach (‘CI’) of 72%. The DF abstraction adequate 70% of the subjects’ boilerplate testosterone levels aural the accustomed ambit (C) acknowledging that alert circadian (‘BID’) dosing is the adapted dosing dieting for LPCN 1021 and will be the base for resubmission.
The adverse accident contour of LPCN 1021 in both the DV and DF studies was constant with the ahead conducted 52-
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