Bioequivalence Study of Two Inhalation Formulations Containing Budesonide 200 µg
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
A SINGLE CENTER, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, TWO PERIOD CROSSOVER STUDY TO DETERMINE
THE BIOEQUIVALENCE OF TWO INHALATION FORMULATIONS CONTAINING BUDESONIDE 200 µg ADMINISTERED
AS 3 PUFFS (TOTAL DOSE OF 600 µg) IN AT LEAST 52 HEALTHY MALES AND FEMALES UNDER FASTING
CONDITIONS
The study objective is to determine whether the inhaled test product, budesonide 200 µg
(pressurized inhalation suspension) and the inhaled reference product, Budesonida Pulmictan®
200 µg (budesonide; pressurized inhalation suspension) are bioequivalent.
For this purpose the PK profile of budesonide will be compared after administration of a
single dose of 600 µg (3 puffs) of each of the two inhalation formulations, under fasting
conditions.