In a single dose clinical study to establish the kinetics and safety of of HMRlignan™ a single doses of HMRlignan™ or placebo were given to healthy male volunteers (sample size 38) with ascending doses (1 to 1200 mg). In the study which had a parallel-group, double-blind design subjects were on a lignan-poor diet one week prior to HMRlignan™ administration and three days thereafter. Plasma concentrations of HMR and enterolactone and other metabolites of HMRlignan™ were measured on days -7 (before starting lignan-poor diet) and -3, and on day 1 just before HMRlignan™ administration, as well as 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours thereafter. The safety was followed by physical examinations, safety laboratory determinations, ECG recordings and evaluation of adverse events.

The study reported the following pharmacokinetic parameters of HMRlignan™:

•	HMRlignan™ was rapidly absorbed.
•	Plasma concentrations increased with increasing dose, and the increases in plasma AUC and Cmax–values appeared to be close to linear.
•	The apparent mean elimination half life (t1/2el) ranged from 2.6 to 5.1 hours, with no sign of dose dependency.
•	Enterolactone was detected as the main metabolite, and it was dose dependently elevated after single HMRlignan™ dosing.
•	Doses as low as 10 mg produced a marked elevation in enterolactone concentration.
•	There were no treatment related adverse effects.