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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taking the medication | Experimental | Participants take the standard breakfast and 30 minutes later the 10 mL suspension containing 500 mg of sodium alginate, 267 mg of sodium bicarbonate, 800 mg of magaldrate and 120 mg of simeticone |
|
| Not taking the medication | No Intervention | Participants take the standard breakfast but don't take the medication |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium alginate + sodium bicarbonate + magaldrate + simeticone | Drug | Take an oral suspension of 10 mL 30 minutes after the ingestion of a standardized breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for Aluminum | To evaluate the Cmax of Aluminum to check if there is any absorption of aluminum and/or magnesium ions after oral administration of the drug in fed conditions | -12:00 / -06:00 / -00:10 (baseline) y 00:10 / 00:20 / 00:30 / 00:40 / 00:50 / 01:00 / 01:15 / 01:30 / 01:45 / 02:00 / 02:15 / 02:30 / 02:45 / 03:00 / 03:30 / 04:00 / 04:30 / 05:00 / 05:30 / 06:00 / 08:00 / 10:00 / 12:00 after drug administration |
| AUC for Aluminum | To evaluate the AUC for Aluminum to check if there is any absorption of aluminum and/or magnesium ions after oral administration of the drug in fed conditions | -12:00 / -06:00 / -00:10 (baseline) y 00:10 / 00:20 / 00:30 / 00:40 / 00:50 / 01:00 / 01:15 / 01:30 / 01:45 / 02:00 / 02:15 / 02:30 / 02:45 / 03:00 / 03:30 / 04:00 / 04:30 / 05:00 / 05:30 / 06:00 / 08:00 / 10:00 / 12:00 after drug administration |
| Cmax for Magnesium | To evaluate the Cmax for Magnesium to check if there is any absorption of aluminum and/or magnesium ions after oral administration of the drug in fed conditions | -12:00 / -06:00 / -00:10 (baseline) y 00:10 / 00:20 / 00:30 / 00:40 / 00:50 / 01:00 / 01:15 / 01:30 / 01:45 / 02:00 / 02:15 / 02:30 / 02:45 / 03:00 / 03:30 / 04:00 / 04:30 / 05:00 / 05:30 / 06:00 / 08:00 / 10:00 / 12:00 after drug administration |
| AUC for Magnesium | To evaluate the AUC for Magnesium to check if there is any absorption of aluminum and/or magnesium ions after oral administration of the drug in fed conditions | -12:00 / -06:00 / -00:10 (baseline) y 00:10 / 00:20 / 00:30 / 00:40 / 00:50 / 01:00 / 01:15 / 01:30 / 01:45 / 02:00 / 02:15 / 02:30 / 02:45 / 03:00 / 03:30 / 04:00 / 04:30 / 05:00 / 05:30 / 06:00 / 08:00 / 10:00 / 12:00 after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of aluminum ions absorbed after drug administration vs amount provided by food | To evaluate the amount of aluminum ions absorbed after drug administration compared to the amount provided by food | -12:00 / -06:00 / -00:10 (baseline) y 00:10 / 00:20 / 00:30 / 00:40 / 00:50 / 01:00 / 01:15 / 01:30 / 01:45 / 02:00 / 02:15 / 02:30 / 02:45 / 03:00 / 03:30 / 04:00 / 04:30 / 05:00 / 05:30 / 06:00 / 08:00 / 10:00 / 12:00 after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAEP | Campinas | São Paulo | 13087-567 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39249590 | Derived | Burgos Castillo MJ, Cruz Palacios MJ, Iorgatchof Xavier K, Calafatti Carandina SA, Arbelaez Quintero I, do Prado Assuncao L. Evaluation of Aluminum and Magnesium Absorption Following the Oral Administration of an Antacid Suspension Containing Magaldrate in Healthy Women Under Fed Conditions. Adv Ther. 2024 Nov;41(11):4089-4097. doi: 10.1007/s12325-024-02969-9. Epub 2024 Sep 9. |
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| ID | Term |
|---|---|
| D000464 | Alginates |
| D017693 | Sodium Bicarbonate |
| C016545 | magaldrate |
| D012841 | Simethicone |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
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|
| D002255 |
| Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |