Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560008
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
A Study to Evaluate the Effect of EnXtra and EnXtra Caffeine on Mental Alertness and Fatigue in Healthy Individuals
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of EnXtra and EnXtra Caffeine on Mental Alertness and Fatigue in Healthy Individuals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Acute Stage The present study is a randomized double-blind placebo-controlled single-dose 4-way cross-over study Approximately not more than 170 individuals will be screened and considering a screening failure rate of 25 approximately 128 individuals will be randomized in a ratio of 1111 to receive one of the IPs and will be assigned a unique randomization code In this stage approximately 114 individuals will complete the study after accounting for a dropoutwithdrawal rate of 15 The intervention duration is 4 days 1 single dose x 4 periods
Sub-Acute Stage The present study is a randomized double-blind placebo-controlled 4 arms parallel study In this stage approximately 112 individuals will be re-randomized in a ratio of 1111 to receive one of the IPs and will be assigned a unique randomization code Each group will have not less than 24 completed participants after accounting for a dropoutwithdrawal rate of 15 The intervention duration is 28 days
Sub-Acute Stage The present study is a randomized double-blind placebo-controlled 4 arms parallel study In this stage approximately 112 individuals will be re-randomized in a ratio of 1111 to receive one of the IPs and will be assigned a unique randomization code Each group will have not less than 24 completed participants after accounting for a dropoutwithdrawal rate of 15 The intervention duration is 28 days
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