Micellar encapsulation will be tested to increase the oral bioavailability in humans of 6-prenylnaringenin (6-PN) from hops (Humulus lupulus). The study follows a single dose (250 mg 6-PN), placebo controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout periods. Plasma, urine and PBMC samples will be collected at intervals up to 24 h after intake of the native compound, the micellar formulation or placebo. The safety, pharmacokinetics and impact of oral prenylflavonoids on PBMC survival will be investigated.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Mean area under the curve (AUC) of plasma concentration vs. time of total 6-PN [nmol/L*h]
Timeframe: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
Mean maximum plasma concentration (Cmax) of total 6-PN [nmol/L]
Timeframe: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
Time to reach maximum plasma concentration (Tmax) of total 6-PN [h]
Timeframe: 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose
Cumulative urinary excretion of total 6-PN [nmol/g creatinine]
Timeframe: 0 h - 24 h post dose
Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration
Timeframe: 0 h, 6 h, and 24 h post dose
Cell viability of PBMCs after 6-PN administration
Timeframe: 0 h, 6 h, and 24 h post dose