NCT03807050

Safety and Pharmacokinetics of Phaffia Rhodozyma Astaxanthin

Safety and Pharmacokinetics of Astaxanthin-Rich Carotenoid Extract (AstaFerm™) Administered as a Single Oral Dose to Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: NextFerm Technologies LTD · Industry
• Sex: Male
• Age: 18 Years – 46 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Absorption; Chemicals

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Astaxanthin	Capsules containing astaxanthin derived from the yeast Phaffia rhodozyma .

Timeline

• Start date: 2018-11-19
• Primary completion: 2018-12-23
• Completion: 2019-02-01
• First posted: 2019-01-16
• Last updated: 2019-03-21

Locations

1 site across 1 country: Israel