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A Clinical Study to Evaluate Z7200 (Budesonide/Formoterol) Pharmacokinetics Profile in Healthy Volunteers

Information source: Zambon SpA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Z7200 (Drug); Symbicort Turbohaler (Drug); Z7200 with charcoal (Drug); Symbicort Turbohaler with charcoal (Drug); Symbicort Turbohaler replicate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Zambon SpA

Official(s) and/or principal investigator(s):
Phil Evans, MBChB, Principal Investigator, Affiliation: Quotient Clinical Limited

Summary

The pharmacokinetics study aims to evaluate the safety of Z7200 (budesonide/formoterol) in comparison with Symbicort Turbohaler (budesonide/formoterol), assessing the bioequivalence of the two products. Namely the study will compare the total systemic bioavailability (as an indicator of safety), and it will compare the pulmonary bioavailability (as a possible surrogate indicator of efficacy). This study will be performed in healthy subjects.

Clinical Details

Official title: An Open-Label, Single-dose, Randomized, Five-Period Cross-over to Compare Pharmacokinetics Profiles of Z7200 and Symbicort Turbohaler, With and Without Charcoal Blockade in Healthy Volunteers.

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Area under the plasma concentration-time curve from time zero to the last detectable level (AUC0-t) of budesonide and formoterol without charcoal blockade.

Maximum plasma level (Cmax) of budesonide and formoterol without charcoal blockade

Secondary outcome:

Area under the plasma concentration-time curve from time zero to the last detectable level (AUC0-t) of budesonide and formoterol with charcoal blockade

Maximum plasma level (Cmax) of budesonide and formoterol with charcoal blockade

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Main Inclusion Criteria:

- Male or female 18 to 45 years of age.

- If female, is currently not pregnant/breast feeding/ or attempting to become pregnant

has a negative serum pregnancy test, or is of non-childbearing potential or is of child-bearing potential, willing to commit to using a consistent and acceptable method of birth control or is of child-bearing potential and not sexually active

- Body mass index (BMI) of 18. 5 to 29. 9 kg/m² inclusive and a body weight ≥50 kg.

Main Exclusion Criteria:

- FEV1 value less than 80% of the predicted value and FEV1/FVC ratio <0. 7.

- History or current evidence of a clinically significant disease or disorder capable

of altering the absorption, metabolism, distribution or elimination of drugs.

- History or current evidence of a clinically significant disease including, but not

limited to: cardiovascular, hepatic, renal, haematological, neuropsychological, endocrine, gastrointestinal or pulmonary.

- Presence of glaucoma, cataracts, ocular herpes simplex, malignancy, regardless of the

clinical significance or current stability of the disease.

- History or presence of silent infections, including positive tests for HIV1, HIV2,

Hepatitis B and Hepatitis C.

- Bacterial or viral infection of the upper respiratory tract (including the common

cold and flu), sinus, or middle ear within 2 weeks of dosing.

- Lower respiratory tract infection/pneumonia within the past 3 months.

- Presence of any disease or condition or regular concomitant treatment (including

vitamins and herbal products) known to interfere with the absorption, distribution, metabolism or excretion of drugs.

- Screening haemoglobin value of less than 1g/dL above the ULN (or 10g/L)

- History of recurrent vasovagal collapses.

- History of anaphylactic/anaphylactoid reactions.

- History of seizures including febrile seizures excluding childhood febrile

convulsions.

- Unable to demonstrate proper inhalation techniques involved in using the delivery

devices at screening.

- Exposure to any investigational drug within 90 days of the Screening Visit.

- Known or suspected hypersensitivity or idiosyncratic reaction to any steroid, any β2

agonist,or to lactose monohydrate, leucine or Tween 80.

- History of allergy to milk protein.

- Use of an inhaled corticosteroid within 30 days or systemic corticosteroid within 60

days of the Screening Visit.

- Use of medications or herbal medicines that are strong cytochrome P450 3A4 (CYP3A4)

inhibitors or inducers within 30 days prior to Screening Visit

- Any clinically significant abnormal laboratory value or physical finding that may

interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.

- Use of caffeine containing beverages more than 600 mg of caffeine/day.

- Current smokers or ex-smokers who have stopped smoking for less than 10 years.

- Recent or current (suspected) drug abuse or positive result in the drugs abuse test.

- Recent or current alcohol abuse (regular drinking more than 21 units per week for

males and more than 14 units per week for females [1 unit = 4 cl spirits or equivalent]).

- Predictable poor compliance, intolerance to charcoal solution, or inability to

communicate well with the study centre personnel or inability to participate in all treatment periods.

- The subject is not able to understand and comply with protocol requirements,

instructions and protocol-stated restrictions, has participated in a clinical research study within the previous three months or has previously been enrolled in this study.

Locations and Contacts

Quotient Clinical Ltd, Ruddington NG11 6JS, United Kingdom
Additional Information

Starting date: September 2014
Last updated: March 4, 2015

Page last updated: August 23, 2015

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