Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution
Status:
Completed
Trial end date:
2018-01-20
Target enrollment:
Participant gender:
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.