NCT02593500

Bioequivalence Study of Two Inhalation Formulations Containing Budesonide 200 µg

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Reig Jofre Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The sponsor has developed a new formulation (test product) of an existing medication (reference product) which is intended for a variation in the existing marketing authorization. The proposed study in healthy males and females is designed to establish a PK profile under fasting conditions for the orally inhaled test and reference products to evaluate bioequivalence. This will be a single-dose, open-label, laboratory-blind, randomized, two-period crossover study with inhalation administered budesonide200 µg conductedunder fasting conditions inat least 52 healthy males and femalesat a single study center. The study will comprise: * Screening period, including serum cortisol levels and documented inhalation training, of maximum 21 days; * Two treatment periods (each of which will include a profile period of 24 hours)separated by a wash-out period of 7 calendar days (minimum number of days based on half-life of the analyte) to 14 calendar days (maximum number of days based on logistical arrangements) between consecutive administrations of the IMP; * A post-study visit within 72 hours of completion of the last treatment period of the study. Participants will be assigned randomly to treatment sequence, prior to the first administration of IMP.

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	Budesonida Pulmictan® 200 µg
DRUG	Budesonide 200 µg

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2015-11-02
• Last updated: 2015-11-02

Locations

1 site across 1 country: South Africa