NCT06367452

Exploratory Pilot Study to Evaluate the Pharmacokinetic Profile of Magaldrate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tecnoquimicas · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 and/or 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 won't. 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sodium alginate + sodium bicarbonate + magaldrate + simeticone	Take an oral suspension of 10 mL 30 minutes after the ingestion of a standardized breakfast

Timeline

• Start date: 2023-10-31
• Primary completion: 2024-01-15
• Completion: 2024-03-30
• First posted: 2024-04-16
• Last updated: 2024-04-16

Locations

1 site across 1 country: Brazil