Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-29 @ 10:00 AM
Study NCT ID:
NCT03552666
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2018-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults
Sponsor:
Church & Dwight Company, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2018-06
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:
The objective of this clinical study is to evaluate and compare the bioequivalence between a single oral dose of vitamin D3 gummy vitamin versus vitamin D3 tablet in healthy adults.
Detailed Description:
The investigators hypothesize that the gummy and tablet preparations of vitamin D3 supplement will be biologically equivalent, as defined by the absence of a statistically significant difference in bioavailability measured as blood levels of vitamin D3 after administration of the same oral dose of vitamin D3 as gummy and tablet supplementation.
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?: