Exploratory Pilot Study to Evaluate the Pharmacokinetic Profile of Magaldrate

NCT06367452 | Completed Phase 4

• 1 other identifier: CAEP 107.001.23
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Amount of aluminum ions absorbed after drug administration vs 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

Study Arms (2)

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

Drug: Sodium alginate + sodium bicarbonate + magaldrate + simeticone

Not taking the medication

NO INTERVENTION

Participants take the standard breakfast but don't take the medication

Interventions

Sodium alginate + sodium bicarbonate + magaldrate + simeticone DRUG

Take an oral suspension of 10 mL 30 minutes after the ingestion of a standardized breakfast

Also known as: Gastrofast Advance

Taking the medication

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants only
• Between 18 and 55 years old
• To be available for inscription in the National Volunteers Registry for Bioequivalence studies of Brazil
• To be in good health or without any significant disease according to the responsible physician, what is stated in the protocol and the results of the laboratory tests and other tests
• To screen negativa for coronavirus (SARS-CoV-2)
• To be able to understand the nature and objective of the study, including the risks and adverse effects
• To act according to the study requirements at all times by signing the informed consent form
• The drug might bring serious risks to the fetus, so the research participant must agree to the use of a safe contraceptive method

You may not qualify if:

• To present flu-like symptoms that, in the medical opinion, are suspected coronavirus infection (SARS-CoV-2) within 7 days prior to the hospitalization period
• To have had direct and significant contact, in medical judgment, with individuals who tested positive for coronavirus (SARS-CoV-2) within 14 days of hospitalization
• To have a known hypersensitivity reaction to the studied medication or chemically related compounds
• Having used any medication within the 14 days prior to the hospitalization period, except contraceptives, in cases in which, based on the half-life of the medication and/or active metabolites, complete elimination can be assumed or that, at the discretion of the responsible investigator/physician, does not interfere with the pharmacokinetics or analytical stage of the study drug
• To have regularly used dietary and vitamin supplements in the 14 days before the start of the study
• To have received any dose of vaccine within the 7 days prior to the hospitalization period
• To have received, within 3 months prior to the study, treatment with any medication known to have a well-defined toxic potential in large organs
• To have participated in any experimental study or ingested any experimental medication within 6 months prior to the start of this study
• Having been hospitalized for any reason up to 8 weeks before the start of the hospitalization period of this study
• Have a history of liver disease, gastrointestinal disease, or other condition that may interfere with the absorption, distribution, metabolism, or excretion of the medication
• Have a history of kidney, respiratory, hematological, cardiac, neurological, neoplastic or psychiatric disease considered clinically significant by medical criteria
• Have a history of cardiac surgery (any type), renal surgery (renal excision or agenesis), gastrointestinal (partial or total removal of the esophagus, stomach, duodenum, jejunum, ileus, ascending colon, transverse colon, descending colon, sigmoid or rectum) and liver or pancreas surgery
• Have any current symptoms or illness, acute or chronic, under monitoring or treatment, significant at the discretion of the investigator/responsible physician
• Electrocardiographic findings not recommended at the doctor's discretion to participate in the study
• Have the results of the laboratory tests performed in the clinical evaluation of recruitment outside the values considered normal, in accordance with the reference values stipulated by the clinical analysis laboratory, unless they are considered not clinically significant by the researcher /responsible doctor

Sponsors & Collaborators

• Tecnoquimicas: lead

Study Sites (1)

CAEP

Campinas, São Paulo, 13087-567, Brazil

Location

Related Publications (1)

• 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.

  PMID: 39249590 DERIVED

MeSH Terms

Interventions

Alginates; Sodium Bicarbonate; magaldrate; Simethicone

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 16, 2024
• Study Start: October 31, 2023
• Primary Completion: January 15, 2024
• Study Completion: March 30, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

BR (1)