Evaluation of the Bioavailability of Methylprednisolone

NACompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

November 5, 2021

Primary Completion Date

November 10, 2021

Study Completion Date

November 12, 2021

Conditions
Methylprednisone AdministrationIntranasal AdministrationIntravenous AdministrationHealthy Subjects
Interventions
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.

Trial Locations (1)

04510

Universidad Nacional Autonoma de Mexico, Mexico City

All Listed Sponsors
lead

Edda Sciutto Conde

OTHER

NCT05649878 - Evaluation of the Bioavailability of Methylprednisolone | Biotech Hunter | Biotech Hunter