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Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution

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ClinicalTrials.gov Identifier: NCT01966692
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : December 28, 2018
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone Propionate Formulation 1 Drug: Fluticasone Propionate Formulation 2 Drug: Fluticasone Propionate Formulation 3 Drug: Fluticasone Propionate Formulation 3* Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
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
Actual Study Start Date : November 2016
Actual Primary Completion Date : January 20, 2018
Actual Study Completion Date : January 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fluticasone Propionate Formulation 1

Fluticasone Propionate Drug formulation 1 administered via Plastiape Monodose Dry powder Inhaler , 500mcg single dose.

See Formulation Development in Detailed Description for details regarding differences in formulations

Drug: Fluticasone Propionate Formulation 1
Fluticasone Propionate dry powder inhaler Formulation 1

Active Comparator: Fluticasone Propionate Formulation 2

Fluticasone Propionate Drug formulation 2 administered via Plastiape Monodose Dry powder Inhaler , 500mcg single dose.

See Formulation Development in Detailed Description for details regarding differences in formulations

Drug: Fluticasone Propionate Formulation 2
Fluticasone Propionate dry powder inhaler Formulation 2

Active Comparator: Fluticasone Propionate Formulation 3

Fluticasone Propionate Drug formulation 3 administered via Plastiape Monodose Dry powder Inhaler , 500mcg single dose.

See Formulation Development in Detailed Description for details regarding differences in formulations

Drug: Fluticasone Propionate Formulation 3
Fluticasone Propionate dry powder inhaler Formulation 3

Active Comparator: Fluticasone Propionate Formulation 3*
Fluticasone Propionate Drug formulation 3 administered via Plastiape Monodose Dry powder Inhaler , 500mcg single dose. * (The asterisk) A different batch of the formulation 3 is given to the patient to ensure that the study is sufficiently powered to show bioequivalence between two batches of the same formulation.
Drug: Fluticasone Propionate Formulation 3*

Fluticasone Propionate dry powder inhaler Formulation 3*

*(The asterisk) A different batch of the formulation 3 is given to the patient to ensure that the study is sufficiently powered to show bioequivalence between two batches of the same formulation.





Primary Outcome Measures :
  1. Area Under the Plasma Concentration versus time curve (AUC) for Drug Fluticasone Propionate [ Time Frame: The participant will be followed for the duration of the four treatment arms, an expected average of 4 weeks ]
    Each volunteer stays in the study for 4 weeks. After 4 weeks the AUC is measured for all 4 treatment arms


Secondary Outcome Measures :
  1. Peak plasma concentration for fluticasone propionate [ Time Frame: The participant will be followed for the duration of the four treatment arms, an expected average of 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or female subjects aged 18 to 50 years (inclusive).
  2. Females will be eligible only if they are currently non-lactating and demonstrate a negative urine pregnancy test. Female subjects must be willing to use highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly e.g. no sexual intercourse, an intrauterine device (IUD), using contraceptive foam AND a condom (double-barrier).
  3. Body weight ranging from 50 to 100 kg, corresponding to a BMI of 18-29 kg/m2.
  4. Non-smoker for at least 12 months prior to study screening and a maximum smoking history of less than ten-pack years (i.e. the equivalent of one-pack per day for ten years).
  5. Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests (including serum cortisol at screening), complete blood count (CBC) with differential, urinalysis and basic metabolic panel.
  6. Ability to read, comprehend and sign the consent form.
  7. Ability and willingness to comply with all study procedures, discontinue and/or withhold medications as specified in the protocol, and attend scheduled study visits.
  8. No history of respiratory disease.
  9. Normal baseline spirometry as predicted for age, sex and height, including forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) > 0.8.
  10. Healthy and without any pre-existing medical conditions.

Exclusion Criteria:

  1. Any history and/or conditions that might interfere with drug absorption, distribution, metabolism or excretion of FP, e.g., pre-existing lung and liver disease.
  2. Known or suspected sensitivity to Flonase (Fluticasone Propionate), Veramyst (Fluticasone Furoate), or related compounds in that class.
  3. Hypersensitivity to milk proteins or lactose (inactive ingredients in the formulation).
  4. Having a history and/or currently having the medical condition in the opinion of medically accountable investigator and hence taking any medication for the following (including but not limited to):

    4.1 Significant cardiac, dermatologic, gastrointestinal, hepatic, renal, hematological, neurological and psychiatric disease (determined by physical exam, CBC with differential, urinalysis, basic metabolic panel and medical history).

    4.2 Presence of glaucoma, cataracts, ocular herpes simplex or carcinoma (other than basal cell).

    4.3 Presence of tuberculosis and other respiratory diseases (including but not limited to intermittent or persistent asthma, emphysema and chronic bronchitis); or respiratory infection, common cold, sinusitis or ear infections.

  5. Current use of hormone replacement therapy (HRT), hormonal contraceptives and/or corticosteroid treatment within the last 2 months.
  6. Smoker during the last 1 year prior to study screening (self-report).
  7. Evidence of a positive pregnancy urine test for female volunteers or females who are pregnant or breast-feeding or are likely to become pregnant during the trial. Women of child-bearing potential may be included in the study if, in the opinion of the investigator, they are taking adequate contraceptive precautions as described above.
  8. Exposure to any investigational drug within 30 days of enrolment.
  9. Subjects who are unable to demonstrate proper inhalation of the test products.
  10. Subjects who have a history of anemia.
  11. Exposure to any medication that alters CYP3A4 activity within last 2 weeks (e.g.: azole antifungals, rifampin).
  12. Nausea, vomiting or diarrhoea within 7 days of dosing.
  13. Subjects who have donated 1 pint (450 mL) of blood or more within the previous 8 weeks prior to study administration.
  14. Any history or current drug or alcohol abuse, which would interfere with the subject's completion of the study and with adherence to the protocol.
  15. A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
  16. The subject is the student of the Principal Investigator (PI).
  17. Lack of willingness to have personal study related data collected, archived and transmitted according to the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966692


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Food and Drug Administration (FDA)
Investigators
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Principal Investigator: Juergen Bulitta, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01966692     History of Changes
Other Study ID Numbers: IRB201400464
00079088 ( Other Identifier: United States: Food and Drug Adminstration )
HHSF223401610099C ( Other Grant/Funding Number: US FOOD AND DRUG ADMN )
OCR15966 ( Other Identifier: University of Florida )
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing of subject's de-identified data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Bioequivalence
Fluticasone Propionate

Additional relevant MeSH terms:
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Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents