Pilot Study to Evaluate Bioavailability of Methylprednisolone Administered Intranasally.
Status:
Completed
Trial end date:
2021-11-12
Target enrollment:
Participant gender:
Summary
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 andin 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 absolute bioavailability of methylprednisolone in healthy subjects
of both genders, with administration. intranasally vs. intravenous dose of 1 ml of
methylprednisolone sodium succinate equivalent to 62.5 mg of methylprednisolone.