Evaluation of the Bioavailability of Methylprednisolone

Healthy Subjects Clinical Trial

Official title: Evaluation of the Bioavailability of Methylprednisolone Succinate Administered Intranasally

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. ;

Related Conditions & MeSH terms

• Healthy Subjects

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