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

NCT02593500 Phase 1 COMPLETED

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.

Details

Lead sponsor	Reig Jofre Group
Phase	Phase 1
Status	COMPLETED
Enrolment	57
Start date	2014-04
Completion	2014-05

Conditions

• Allergy

Interventions

• Budesonida Pulmictan® 200 µg
• Budesonide 200 µg

Primary outcomes

• Cmax — Up to 24 hours
  Maximum observed plasma concentration (Cmax) obtained directly from the concentration-time data
• AUC(0-t) — Up to 24 hours
  Area under the plasma concentration versus time curve (AUC), from time zero to t, where t is the time of the last quantifiable concentration (AUC(0-t)).

Countries

South Africa