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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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

Detailed Summary:

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.

Sponsor: Galilee CBR

Current Primary Outcome: Mean fractional absorption [ Time Frame: 6 hours ]

A comparison of mean fractional absorption of the two Multivitamin mineral formulations (gel vs. tablet/capsule).


Original Primary Outcome: Same as current

Current Secondary Outcome: Absorption rate [ Time Frame: 6 hours ]

A comparison of absorption rate across the two Multivitamin mineral formulations (gel vs. tablet/capsule).


Original Secondary Outcome: Same as current

Information By: Galilee CBR

Dates:
Date Received: May 6, 2017
Date Started: May 9, 2017
Date Completion: July 1, 2017
Last Updated: May 6, 2017
Last Verified: May 2017