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

Galilee Clinical Bio Research

Status: Completed

Conditions: Vitamin Deficiency

Treatments: Dietary Supplement: Multivitamins

Study type: Interventional

Funder types: Industry

Identifiers

NCT03146273

SSPA-17-1

Details and patient eligibility

About

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

Full description

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

1. 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.
2. 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Tablet

Active Comparator group

Description:

The tablet/capsule will be administered as a single dose of Multivitamins in tablet 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. The results will be used for the AUC calculation of the absorption in order to compare with the Gel administration absorption.

Treatment:

Dietary Supplement: Multivitamins

Gel

Active Comparator group

Description:

The gel will be administrated to the same group of patients in the single dose of Multivitamins in gel 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. The results will be used for the AUC calculation of the absorption in order to compare with the Tablet administration absorption.

Treatment:

Dietary Supplement: Multivitamins