Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367452
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-03-20
Brief Title:
Exploratory Pilot Study to Evaluate the Pharmacokinetic Profile of Magaldrate
Sponsor:
Tecnoquimicas
Organization:
Tecnoquimicas
Study Overview
Official Title:
Exploratory Pilot Study to Evaluate the Pharmacokinetic Profile of Magaldrate
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical pilot study is to evaluate the pharmacokinetic profile of magaldrate in a group of 10 healthy women after the administration of a 10 mL drug suspension containing 500 mg of sodium alginate 267 mg of sodium bicarbonate 800 mg of magaldrate and 120 mg of simeticone The main question it aims to answer is the amount of magnesium andor aluminum if any absorbed into the plasma from this oral administration
Participants will take the medication 30 minutes after a standard breakfast Both groups of participants will take the standard meal but one group will take the medication and the other one wont
Researchers will compare the levels of both ions in plasma in a group to see if there is any absorption quantifying the basal plasma levels and comparing with the levels obtained after the meal and the medication when it applies
Participants will take the medication 30 minutes after a standard breakfast Both groups of participants will take the standard meal but one group will take the medication and the other one wont
Researchers will compare the levels of both ions in plasma in a group to see if there is any absorption quantifying the basal plasma levels and comparing with the levels obtained after the meal and the medication when it applies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None