A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults

Church & Dwight Company, Inc.1 site in 1 country9 target enrollmentDecember 26, 2016

ConditionsBioequivalence of Vitamin D in Healthy Adults

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bioequivalence of Vitamin D in Healthy Adults
Sponsor: Church & Dwight Company, Inc.
Enrollment: 9
Locations: 1
Primary Endpoint: Mean Absorption
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 26, 2016

End Date

March 27, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Church & Dwight Company, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Females not of childbearing potential (i.e., hysterectomy, oophorectomy, bilateral tubal ligation or postmenopausal) or females of childbearing potential that agree to use a medically approved method of birth control such as hormonal contraceptives, double-barrier, non-hormonal intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) and/or vasectomy of partner
•BMI 18.5 to 29.9 kg/m2
•Agrees to maintain current level of physical activity throughout the study
•Agrees to wear sunblock of at least SPF 45 during the study and not to have excessive sun exposure (no more than 1 hour without sunblock)

Exclusion Criteria

•Women who are pregnant to be determined by UPT (urine pregnancy test), breastfeeding, or planning to become pregnant during the course of the study
•Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or GERD within the past 3 months
•Significant gastrointestinal disease, history of malabsorption, or history of irritable bowel syndrome and related disorders
•Unstable medical conditions as determined by the principal investigator
•Clinically significant abnormal laboratory results on CBC or BMP at screening
•Cancer chemotherapy/radiation treatment within the 3 months prior to enrollment
•Metabolic disease
•History of kidney stones
•Use of prescription or over the counter products known to interact with vitamin D within 72 hours of randomization and during the trial such as aspirin and NSAIDs, aluminum, iron and proton pump inhibitors
•Use of acute over the counter medication within 72 hours of test product dosing