Ijm. Duijkers et al., PHARMACOKINETICS OF 2 HUMAN MENOPAUSAL GONADOTROPIN PREPARATIONS AFTER SINGLE INTRAVENOUS ADMINISTRATION DURING PITUITARY SUPPRESSION, Human reproduction, 10(6), 1995, pp. 1367-1372
A randomized study was performed in nine healthy women, to investigate
pharmacokinetic parameters and bioequivalence of two human menopausal
gonadotrophin preparations after i.v. administration, Endogenous gona
dotrophin activity was suppressed by triptorelin administration, Humeg
on and Pergonal (225 IU of each) were injected i.v. in a cross-over wa
y with an interval of 1 week, Blood samples were collected frequently
and serum concentrations of follicle stimulating hormone (FSH), lutein
izing hormone (LH), specific LH, and human chorionic gonadotrophin (HC
G) were determined by fluoroimmunoassays assays, Serum LH bioactivity
was measured by an in-vitro bioassay, The area under curve (AUG) and h
alf-life of FSH were respectively 431.5 IU h/l and 22.20 h for Humegon
, and 402.6 IU h/l and 21.33 h for Pergonal, For both preparations, th
e (total) LH immunoactivity and in-vitro bioactivity of serum LH were
very similar, and appeared to be a composite of specific LH and HCG ac
tivity, The AUC data of specific LH were 17.50 IU h/l for Humegon and
21.79 IU h/l for Pergonal respectively, The AUC and half-life of HCG w
ere 153.7 IU h/l and 14.80 h for Humegon, and 134.1 IU h/l and 12.11 h
for Pergonal, The two preparations were bioequivalent with respect to
FSH and HCG immunoreactivity, Bioequivalence could not be proven for
LH activity because of the small number of subjects.