NCT05647408

Evaluation of the Bioavailability of Dexamethasone in Healthy Subjects

Open Pilot Study to Evaluate the Bioavailability of Dexamethasone Administered Through Intranasal vs Intravenous Route.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Universidad Nacional Autonoma de Mexico · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dexamethasone Administration
• Intranasal Administration
• Inflammation
• Intravenous Drug Usage
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Dexamethasone	The nominal doses were similar, volunteers were randomly assigned to receive a single dose of DXM by IV bolus of 1.5 mL (equivalent to 6 mg of dexamethasone) or the same dose 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: 2021-11-06
• Completion: 2021-11-13
• First posted: 2022-12-12
• Last updated: 2022-12-12

Locations

1 site across 1 country: Mexico