Allergy Clinical Trial - Bioequivalence Study of Two Inhalation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Allergy

Clinical Trial Details

NCT number	NCT02593500
Study type	Interventional
Source	Reig Jofre Group
Contact
Status	Completed
Phase	Phase 1
Start date	April 2014
Completion date	May 2014

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Bioequivalence Study of Two Inhalation Formulations Containing Budesonide 200 µg

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms