Safety and Pharmacokinetics of Phaffia Rhodozyma Astaxanthin
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|ClinicalTrials.gov Identifier: NCT03807050|
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : March 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Absorption; Chemicals||Dietary Supplement: Astaxanthin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Pharmacokinetics of Astaxanthin-Rich Carotenoid Extract (AstaFerm™) Administered as a Single Oral Dose to Healthy Adults|
|Actual Study Start Date :||November 19, 2018|
|Actual Primary Completion Date :||December 23, 2018|
|Actual Study Completion Date :||February 1, 2019|
Astaxanthin capsules containing 50 milligram astaxanthin derived from the yeast Phaffia rhodozyma (Xanthophyllomyces dendrorhous)
Dietary Supplement: Astaxanthin
Capsules containing astaxanthin derived from the yeast Phaffia rhodozyma .
Other Name: AstaFerm
- Cmax [ Time Frame: Estimated to be at 8 to 10 hours after dosing ]The maximum plasma concentration obtained in average of 12 subjects
- AUC 0-t [ Time Frame: 168 hours after dosing ]Calculate Area under the plasma concentration versus time curve from time =0 h to time of the last measurable concentration of 12 subjects
- Time max [ Time Frame: Estimated to be at 8 to 10 hours after dosing ]Time at which Cmax occurs
- Adverse Events (AEs) [ Time Frame: 15 days ]Number of subjects that reported incidence of adverse events and details of adverse events that were reported
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807050
|Sourasky Medical Center|
|Tel-Aviv, Israel, 6423906|
|Principal Investigator:||Oren Shibolet, Prof.||Tel Aviv Sourasky Medical Center Israel|