Evaluation of the Bioavailability of Dexamethasone in Healthy Subjects
Status:
Completed
Trial end date:
2021-11-13
Target enrollment:
Participant gender:
Summary
The most important property of a dosage of a drug administration 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. Dexamethasone 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 dexamethasone 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 (for information purposes) of
Dexamethasone 8 mg/2 ml Injectable Solution (Intranasal Route 6 mg/ 1.5 ml Vs Intravenous
Route 6 mg/ 1.5 ml), according to the specific evaluation parameters and general under
fasting conditions.