Bioequivalence Study to Assess Systemic Exposure of FP and SAL FDC From Different DPIs

NCT02215122 | Completed Phase 1

• 1 other identifier: MGR001-1008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a crossover study to assess the systemic pharmacokinetics of fluticasone propionate (FP) and salmeterol (SAL). Study medication will be administered as fixed dose combinations (250 µg FP and 50 µg SAL) from the Advair® Diskus®, Seretide™ Accuhaler™ and CRC749 inhalers.

Conditions

Asthma; COPD

Keywords

Fluticasone Propionate; Salmeterol; Pharmacokinetics; Healthy Subjects; MGR001; CRC749; Dry Powder Inhaler; generic; Advair Diskus; Seretide Accuhaler

Outcome Measures

Primary Outcomes (2)

• AUC for each of the treatment groups FP/SAL

  3 days of each treatment period.

• Cmax for each of the treatment groups FP/SAL,

  3 days of each treatment period.

Secondary Outcomes (2)

• Adverse events

  Day1 to Day3

• Inspiratory Flow assessments

  Day 1 pre-dose

Study Arms (3)

MGR001

EXPERIMENTAL

FP/SAL 250/50 µg 3 x inhalations (total dose 750/150 µg) administered via CRC749 inhaler.

Drug: MGR001

Advair® Diskus®

EXPERIMENTAL

FP/SAL 250/50 µg 3 x inhalations (total dose 750/150 µg) administered via Diskus® inhaler.

Drug: Advair® Diskus®

Seretide™ Accuhaler™

EXPERIMENTAL

FP/SAL 250/50 µg 3 x inhalations (total dose 750/150 µg) administered via Accuhaler™ inhaler.

Drug: Seretide™ Accuhaler™

Interventions

MGR001 DRUG

Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA)

Also known as: FP, SAL

MGR001

Advair® Diskus® DRUG

Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA)

Also known as: FP, SAL

Advair® Diskus®

Seretide™ Accuhaler™ DRUG

Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA)

Also known as: FP, SAL

Seretide™ Accuhaler™

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female subjects between the ages of 18 and 55 years.
• Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).
• An informed consent document signed and dated by the subject.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 14 units/week for females or 21 units/week for males (1 unit = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
• Treatment with an investigational drug within 30 days or 5 half-lives or as determined by the local requirement, whichever is longer, preceding the first dose of study medication.
• lead ECG demonstrating QTcF \>450 msec or a QRS interval \>120 msec at screening. If QTcF exceeds 450 msec or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTcF or QRS values should be used to determine the subject's eligibility.
• Hemoglobin \<11.5 g/dL for female subjects or \<12.5 g/dL for male subjects.
• Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol.
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued at least 28 days prior to the first dose of study medication. - Blood donation of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
• Unwilling or unable to comply with the lifestyle guidelines described in this protocol.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
• Evidence or significant history of childhood or adult asthma, or any significant history of wheeze, chronic cough, dyspnea at rest or acute bronchospasm.
• Subjects with abnormal lung function tests at screening, defined as an FEV1 and/or FVC which is \<80% of predicted.
• Subjects who are current smokers. Ex-smokers who have given up smoking for \<6 months and/or have a smoking pack history of ≥10 pack years.
• Subjects with a lower respiratory tract infection in the 4 weeks prior to dosing.
• History of sensitivity to lactose or sensitivity to the ingredients of Advair®/Seretide™, including subjects with severe milk protein allergy in whom Advair® is contraindicated.

Sponsors & Collaborators

• Mylan Pharma UK Ltd.: lead

Study Sites (1)

Worldwide Clinical Trials Early Phase Services

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jon Ward

  Mylan Pharma UK Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 13, 2014
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 7, 2022

Record last verified: 2022-02

Locations

US (1)