NCT05649878

Evaluation of the Bioavailability of Methylprednisolone

Evaluation of the Bioavailability of Methylprednisolone Succinate Administered Intranasally

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Edda Sciutto Conde · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Methylprednisone Administration
• Intranasal Administration
• Intravenous Administration
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Evaluation of bioavailability of methylprednisolone succinate administered intravenously	Bioavailability of methylprednisolone in healthy subjects of both genders, when administered intravenously. The nominal doses were similar, volunteers were randomly assigned to receive a single dose of MEP by IV bolus of 1.5 mL. Venous blood samples were obtained via an indwelling catheter before administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 and 24 h for DXM. Plasma was separated and frozen at -70 °C for further analysis.
DRUG	Evaluation of bioavailability of methylprednisolone succinate administered intranasally	Bioavailability of methylprednisolone in healthy subjects of both genders, when administered intranasally. Volunteers were randomly assigned to receive a single dose of MEP intranasally by using a Mucosal Atomization Device (MAD Nasal). allowing direct pharmacokinetic comparison without dose normalization. Venous blood samples were obtained via an indwelling catheter before administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 and 24 h for DXM. Plasma was separated and frozen at -70 °C for further analysis.

Timeline

• Start date: 2021-11-05
• Primary completion: 2021-11-10
• Completion: 2021-11-12
• First posted: 2022-12-14
• Last updated: 2022-12-16

Locations

1 site across 1 country: Mexico