Ignite Creation Date:
2024-05-06 @ 2:06 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01966692
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2013-09-30
Brief Title:
Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Evaluation of the Sensitivity of Pharmacokinetics to Differences in the Aerodynamic Particle Size Distribution of Three Different Formulations of Fluticasone Propionate Dry Powder Inhalers
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Formulation Development
The aim of the pharmaceutical development was to manufacture three Dry powder Inhalation DPI formulations containing Fluticasone Propionate in an Plastiape Monodose DPI device which provide distinct in vitro deposition patterns on a Next Generation Impactor NGI is a high performance cascade impactor used to characterize aerosol particles by particle size It is desirable to develop three formulations with the same emitted dose ED impactor size mass ISM but different mass median aerodynamic diameter MMAD Meeting these design criteria for the formulations would help to see if pharmacokinetic parameters are sensitive to regional differences in drug deposition whilst having the dose deposited in the lung from different formulations being the sameThe three formulation developed are labeled Fluticasone Propionate Drug formulation 1 through 3
Study Procedures and scheduling
The study is comprised of 5 visits in total - a screening visit and 4 treatment visits At least 5 days should lapse between the treatment visits
Screening Visit During the screening visit the inclusion and exclusion criteria will be reviewed to ensure the volunteer is appropriate for the study The informed consent will be reviewed with the volunteer by a member of the study team and the volunteer will be encouraged to ask questions to ensure the volunteer has a good understanding of the study If the volunteer is eligible and agrees to participate the volunteer will be asked to sign the informed consent form prior to any study specific procedures including randomization After the volunteer signs the informed consent the volunteer will be interviewed and demographic data medical history and concomitant medications will be collected and recorded A physical examination will be performed after the vital sign measurements are obtained A pregnancy test for female volunteers will be obtained Spirometry testing and inhalation training will be performed by a qualified study clinicianinvestigator to ensure the suitability of volunteers Laboratory tests including a Complete Blood Count CBC urinalysis and metabolic panel will be collected via venipuncture and processed in the lab Screening tests will be performed within 14 days of treatment visit 1 and no later than 2 days before treatment visit 1 All screening results will be evaluated by the study clinicianinvestigator against the inclusionexclusion criteria to confirm the eligibility of the volunteers
Inhalation training Inhalation training will be performed by a qualified study clinician at the screening visit and at each study visit The training will be accomplished by instructions and subsequent inhalation via training devices containing empty capsules The instructions on how to use the device correctly are similar to the Foradil Aerolizer DPI product information label httpwwwrxlistcomforadil-drugmedication-guidehtm
Treatment Visits 1 2 3 and 4 Eligible volunteers will be asked to return for treatment visit 1 A minimum period of 5 days should lapse between the subsequent treatment visits Each treatment visit is scheduled for 28 hours over two days The study will be conducted at the University of Florida UF CRC Clinical Research Center It is an outpatient study and the volunteer will be asked to come back the following day for the 24 hour blood sample The volunteer will be asked to stay in an outpatient room during the treatment visit The same activities are carried out at the other treatment visits
At each treatment visit eligibility criteria will be reviewed and confirmed to ensure volunteer is appropriate for study Changes in medical history including concomitant medications will be documented Vital signs will be obtained Inhalation training will be provided to the volunteers as mentioned in the section above An IV catheter will be inserted in a vein located in the forearm region of the volunteer The IV catheter is used to avoid multiple pricks while collecting blood samples The IV catheter is not used for the administration of the drug The volunteer inhales 5 times from a given inhaler during each treatment visit Each inhaler will be used only once and by only one volunteer to ensure the volunteers safety from infectious agents The schedule below summarizes the procedures performed at the screening visit and a single treatment visit
Blood sample collection Blood samples will be drawn by inserting an indwelling catheter into the volunteers median cubital vein in the forearm region Blood samples will be taken 15 minutes prior to the dosing of the product pre-dose sample and 5 10 15 20 30 45 60 minutes 15 2 3 4 6 8 10 12 14 and 24 hours post dosing At each time point 9ml of blood sample will be collected of which the first 1ml will be discarded and the remaining 8 ml will be stored in a vacutainer tube for plasma preparation and storage
The aim of the pharmaceutical development was to manufacture three Dry powder Inhalation DPI formulations containing Fluticasone Propionate in an Plastiape Monodose DPI device which provide distinct in vitro deposition patterns on a Next Generation Impactor NGI is a high performance cascade impactor used to characterize aerosol particles by particle size It is desirable to develop three formulations with the same emitted dose ED impactor size mass ISM but different mass median aerodynamic diameter MMAD Meeting these design criteria for the formulations would help to see if pharmacokinetic parameters are sensitive to regional differences in drug deposition whilst having the dose deposited in the lung from different formulations being the sameThe three formulation developed are labeled Fluticasone Propionate Drug formulation 1 through 3
Study Procedures and scheduling
The study is comprised of 5 visits in total - a screening visit and 4 treatment visits At least 5 days should lapse between the treatment visits
Screening Visit During the screening visit the inclusion and exclusion criteria will be reviewed to ensure the volunteer is appropriate for the study The informed consent will be reviewed with the volunteer by a member of the study team and the volunteer will be encouraged to ask questions to ensure the volunteer has a good understanding of the study If the volunteer is eligible and agrees to participate the volunteer will be asked to sign the informed consent form prior to any study specific procedures including randomization After the volunteer signs the informed consent the volunteer will be interviewed and demographic data medical history and concomitant medications will be collected and recorded A physical examination will be performed after the vital sign measurements are obtained A pregnancy test for female volunteers will be obtained Spirometry testing and inhalation training will be performed by a qualified study clinicianinvestigator to ensure the suitability of volunteers Laboratory tests including a Complete Blood Count CBC urinalysis and metabolic panel will be collected via venipuncture and processed in the lab Screening tests will be performed within 14 days of treatment visit 1 and no later than 2 days before treatment visit 1 All screening results will be evaluated by the study clinicianinvestigator against the inclusionexclusion criteria to confirm the eligibility of the volunteers
Inhalation training Inhalation training will be performed by a qualified study clinician at the screening visit and at each study visit The training will be accomplished by instructions and subsequent inhalation via training devices containing empty capsules The instructions on how to use the device correctly are similar to the Foradil Aerolizer DPI product information label httpwwwrxlistcomforadil-drugmedication-guidehtm
Treatment Visits 1 2 3 and 4 Eligible volunteers will be asked to return for treatment visit 1 A minimum period of 5 days should lapse between the subsequent treatment visits Each treatment visit is scheduled for 28 hours over two days The study will be conducted at the University of Florida UF CRC Clinical Research Center It is an outpatient study and the volunteer will be asked to come back the following day for the 24 hour blood sample The volunteer will be asked to stay in an outpatient room during the treatment visit The same activities are carried out at the other treatment visits
At each treatment visit eligibility criteria will be reviewed and confirmed to ensure volunteer is appropriate for study Changes in medical history including concomitant medications will be documented Vital signs will be obtained Inhalation training will be provided to the volunteers as mentioned in the section above An IV catheter will be inserted in a vein located in the forearm region of the volunteer The IV catheter is used to avoid multiple pricks while collecting blood samples The IV catheter is not used for the administration of the drug The volunteer inhales 5 times from a given inhaler during each treatment visit Each inhaler will be used only once and by only one volunteer to ensure the volunteers safety from infectious agents The schedule below summarizes the procedures performed at the screening visit and a single treatment visit
Blood sample collection Blood samples will be drawn by inserting an indwelling catheter into the volunteers median cubital vein in the forearm region Blood samples will be taken 15 minutes prior to the dosing of the product pre-dose sample and 5 10 15 20 30 45 60 minutes 15 2 3 4 6 8 10 12 14 and 24 hours post dosing At each time point 9ml of blood sample will be collected of which the first 1ml will be discarded and the remaining 8 ml will be stored in a vacutainer tube for plasma preparation and storage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OCR15966 | OTHER | University of Florida | None |
| 00079088 | OTHER | None | None |
| HHSF223401610099C | OTHER_GRANT | None | None |