Trial | NCT03146273  Report issue

Title

Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)
A Pharmacokinetic Crossover Comparison Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals defined in the protocol
This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals:

Tablet/capsule administration - up to 20 healthy volunteers will be recruited to the study. The tablet/capsule will be administered as a single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs.
Gel administration - the gel will be administrated to the same group of patients in the single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs.
Study Started
May 09
2017
Anticipated
Primary Completion
Jun 10
2017
Anticipated
Study Completion
Jul 01
2017
Anticipated
Last Update
May 09
2017

Dietary Supplement Multivitamins

After the study product administration blood tests will be performed in order to calculate the AUC for each mineral and vitamin - Vit A Vit E Folic Acid Vit C Calcium Magnesium After the washout period, the same procedure will be done for the additional formulation of the multivitamins.

A Experimental

The tablet/capsule will be administered as a single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs.

B Experimental

The gel will be administrated to the same group of patients in the single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs

Criteria 

Inclusion Criteria:

Healthy male or female and aged 18-65 years
BMI - 19-24
Subject is not pregnant and is not nursing
Signed Informed Consent Form

Exclusion Criteria:

Current use of multivitamin or mineral complexes (washout of 4 days before Visit 2 is permitted)
Participants with known vitamins or mineral deficiencies
Diabetes Type II
Smoking
Subjects who have undergone surgery within the last 3 months.
Subjects with a clinically significant (during last 3 months) infectious, immune-mediated or active malignant disease.
Subjects who are receiving an elemental diet or parenteral nutrition.
Subjects who are treated with insulin.
Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
Subjects who will be unavailable for the duration of the trial, who are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
Known sensitivity to any ingredients in the study product
History of addiction or drug abuse
Alcoholic regular use
No Results Posted