Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT03807050
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2019-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of Phaffia Rhodozyma Astaxanthin
Sponsor:
NextFerm Technologies LTD
Organization:
Study Overview
Official Title:
Safety and Pharmacokinetics of Astaxanthin-Rich Carotenoid Extract (AstaFerm™) Administered as a Single Oral Dose to Healthy Adults
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: