Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution

Summary

When a drug company first develops a drug, the company has to show the Food and Drug Administration (FDA) that the drug is safe and effective. If FDA concludes that the drug is safe and effective, FDA approves the drug. The company can then sell the drug, which the company does using "trade name." Only the drug company that developed the "trade name" drug is allowed to sell it. However, other drug companies can create their own version of the "trade name" drug, which usually happens after the patents for the "trade name" product run out. These drugs, often called "generic drugs," potentially will be less expensive for the patient. In order to sell generic drugs, drug companies must show that their generic version is the same as the "trade name" drug in a number of ways. For example, they generally have to show that their product is intended to be used to treat the same diseases or conditions, that it has the same label, and that the product has the same active ingredient as the "trade name" drug. The generic company also has to show that generic product is "bioequivalent" to the trade name drug, meaning that the generic product gets to the part of the body where the drug works at the same rate that the trade name drug does. How to show how much drug gets to the part of the body where it works, and how fast, depends on the type of product the drug is. The primary aim of this research study is to aid the FDA in finding methods to ensure that the versions of generic drugs that are inhaled (for example, drugs used to treat asthma) are bioequivalent to the trade name drug. As a part of the research study, pharmacokinetic (PK) studies (studies measuring drug levels in the blood over time after inhalation) will be done using three different versions of fluticasone propionate (FP, a drug routinely used in asthmatic patients) administered using a dry powder inhaler (DPI, an inhalation device that delivers the drug as a dry powder). The results from this study will help FDA ensure that generic products are the same as the trade name drugs.

Conditions

• Asthma

Interventions

DRUG

Fluticasone Propionate Formulation 1

Fluticasone Propionate dry powder inhaler Formulation 1

DRUG

Fluticasone Propionate Formulation 2

Fluticasone Propionate dry powder inhaler Formulation 2

DRUG

Fluticasone Propionate Formulation 3

Fluticasone Propionate dry powder inhaler Formulation 3

DRUG

Fluticasone Propionate Formulation 3*

Fluticasone Propionate dry powder inhaler Formulation 3\* \*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.

Sponsors & Collaborators

• Food and Drug Administration (FDA)

  collaborator FED

• University of Florida

  lead OTHER

Principal Investigators

• Juergen Bulitta, PhD · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-11-30

Primary Completion

2018-01-20

Completion

2018-01-20

FDA Drug

Yes

Countries

• United States

Study Locations