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Bioequivalence Study of Two Inhalation Formulations Containing Budesonide 200 µg

NCT02593500 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2015-11-02

No results posted yet for this study

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.

Conditions

  • Allergy

Interventions

DRUG

Budesonida Pulmictan® 200 µg

DRUG

Budesonide 200 µg

Sponsors & Collaborators

  • Reig Jofre Group

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02593500 on ClinicalTrials.gov