Astaxanthin is a xanthophyll carotenoid, a naturally occurring lipid-soluble red pigment. Apart from its coloring ability it is also a strong antioxidative ingredient and contains health-promoting properties. Study aim is to monitor the safety and tolerability of AstaFerm™, an astaxanthin dietary supplement derived from the yeast Phaffia rhodozyma. Pharmacokinetics profile is tested in 12 healthy male adults who received a single dose of AstaFerm™ in a single-center, open-label, non-randomized, single-dose study. Subjects are admitted to the clinical research center on the evening before dosing. On the next morning, after overnight fast, pre-dosing plasma sampling is performed, then they receive a fat balanced breakfast followed by a single administration of AstaFerm™ capsules. The capsules contain 50 milligram astaxanthin derived from Phaffia rhodozyma. Following dosing, blood sampling is performed for 24 hours in-house (2, 4, 6, 8, 10, 12 and 24-hours post-dose) and ambulatory at 48, 72- and 168-hours post-dose. Blood for antioxidant activity assessment is also drawn.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
Capsules containing astaxanthin derived from the yeast Phaffia rhodozyma .
Sourasky Medical Center
Tel Aviv, Israel
Cmax
The maximum plasma concentration obtained in average of 12 subjects
Time frame: Estimated to be at 8 to 10 hours after dosing
AUC 0-t
Calculate Area under the plasma concentration versus time curve from time =0 h to time of the last measurable concentration of 12 subjects
Time frame: 168 hours after dosing
Time max
Time at which Cmax occurs
Time frame: Estimated to be at 8 to 10 hours after dosing
Adverse Events (AEs)
Number of subjects that reported incidence of adverse events and details of adverse events that were reported
Time frame: 15 days
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