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

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

Detailed Description
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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.

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

Conditions
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Vitamin Deficiency

Intervention / Treatment
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* Dietary Supplement: Multivitamins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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. | Dietary Supplement: Multivitamins<br>* 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.<br>|
| Experimental: B<br>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 | Dietary Supplement: Multivitamins<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean fractional absorption | A comparison of mean fractional absorption of the two Multivitamin mineral formulations (gel vs. tablet/capsule). | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absorption rate | A comparison of absorption rate across the two Multivitamin mineral formulations (gel vs. tablet/capsule). | 6 hours |