Evaluation of the Bioavailability of Methylprednisolone

Status Completed

Clinical Trial Summary

This study is aimed to evaluate the bioavailability of methylprednisolone in healthy subjects of both genders, with administration intranasally versus intravenous

Clinical Trial Description

The most important property of a drug dosage is its ability to deliver the active ingredient to the site of action in a quantity sufficient to exert the expected pharmacological effect. This ability is known as bioavailability. Methylprednisolone is a drug with wide clinical use in patients with inflammatory pathologies (infectious or non-infectious). The main routes of administration are oral and intravenous. The intranasal route could be one more effective, less invasive that would allow to obtain a faster therapeutic concentration and in greater concentration in the lungs and in the central nervous system than the intravenous route, maintaining very similar systemic concentrations to those achieved intravenously. For these reasons, it is important to know the bioavailability of methylprednisolone administered by this route in order to establish the best dosing regimen. The pilot study is of an exploratory nature (descriptive, comparative or informative), whose objective is to know the pharmacokinetic characteristics of a new route of administration of a drug in the study population to establish the pharmacokinetic parameters, and the comparison between the intranasal bioavailability against the intravenous administration by determining confidence intervals and calculating one-sided double t of Scuirmann. Objetive: To evaluate the bioavailability of methylprednisolone in healthy subjects of both genders, with administration intranasally versus intravenous dose of 1 ml of methylprednisolone sodium succinate equivalent to 62.5 mg of methylprednisolone. ;

Study Design

Related Conditions & MeSH terms

Healthy Subjects

Clinical Trial Details

NCT number	NCT05649878
Study type	Interventional
Source	Universidad Nacional Autonoma de Mexico
Contact
Status	Completed
Phase	N/A
Start date	November 5, 2021
Completion date	November 12, 2021

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