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NCT01966692 · ClinicalTrials.gov registry record · Phase 1
Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution
A Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01966692 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 24 participants.
The verdict
NCT01966692, a Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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 e
Interventions
- DRUG Fluticasone Propionate Formulation 1
- DRUG Fluticasone Propionate Formulation 2
- DRUG Fluticasone Propionate Formulation 3
- DRUG Fluticasone Propionate Formulation 3*
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-11 |
| Est. Completion | 2018-01-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01966692
The ClinicalTrials.gov registry entry for NCT01966692 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fluticasone Propionate Formulation 1 is the first listed.
NCT01966692 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01966692 about?
NCT01966692 is a clinical study titled "Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution". 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." O...
What is the current status of trial NCT01966692?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-11. Estimated completion is 2018-01-20.
What interventions are being tested in trial NCT01966692?
The interventions under investigation include: Fluticasone Propionate Formulation 1 (DRUG), Fluticasone Propionate Formulation 2 (DRUG), Fluticasone Propionate Formulation 3 (DRUG), Fluticasone Propionate Formulation 3* (DRUG).
Who is sponsoring clinical trial NCT01966692?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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