Pharmacokinetic and pharmacodynamic comparison of subcutaneous versus intramuscular leuprolide acetate formulations in male subjects.

ABSTRACT:

Background

The aim of this study was to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of two distinct formulations of leuprolide acetate (LA); subcutaneous (SC) injection and intramuscular (IM) injection.

Methods

A total of 32 healthy men were randomized to receive a single 7.5 mg injection of SC-LA (n = 16) or IM-LA (n = 16) in this phase I, open-label, parallel-group study. PK was assessed via LA concentrations, and PD via serum luteinizing hormone (LH) and testosterone (T) concentrations.

Results

The initial surge of LA was higher for IM-LA than SC-LA (C_max 27 ± 4.9 versus 19 ± 8.0 ng/ml, respectively), with a shorter t_max (1.0 ± 0.4 versus 2.1 ± 0.8 h). The duration of quantifiable LA co

SUBMITTER: Saltzstein D 

PROVIDER: S-EPMC5805007 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature