Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524674
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-11
Brief Title:
Clinical Study to Compare the Effect of an Oral Rehydration Solution on the Rate of Absorption of Functional Ingredients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Blind Controlled Cross-Over Clinical Study to Compare the Effect of an Oral Rehydration Solution on the Rate of Absorption of Functional Ingredients
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study was to compare the individual pharmacokinetics of functional ingredients included in an oral rehydration solution ORS with or without the inclusion of active base ingredients carbohydrate and electrolytes The functional ingredients included in both the control and test solutions were Melatonin in conjunction with L-theanine Arm 1 Caffeine in conjunction with L-theanine Arm 2 and Vitamin C in conjunction with Zinc Arm 3 across two study periods
The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient These included maximum observed concentration C max time of maximum observed concentration T max cumulative Area Under the Curve AUC for each timepoint including AUC from the time of dosing to the time of last observation and the concentration at each timepoint for the corresponding functional ingredients included in the specific study arm ie melatonin L-theanine caffeine vitamin C and zinc
The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient These included maximum observed concentration C max time of maximum observed concentration T max cumulative Area Under the Curve AUC for each timepoint including AUC from the time of dosing to the time of last observation and the concentration at each timepoint for the corresponding functional ingredients included in the specific study arm ie melatonin L-theanine caffeine vitamin C and zinc
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None