Completed

A Bioequivalence Study to Assess the Systemic Exposure of Fluticasone Propionate and Salmeterol Administered as a Fixed Dose Combination From Different Dry Powder Inhalers in Healthy Subjects

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What is being tested

MGR001

+ Advair® Diskus®

+ Seretide™ Accuhaler™

Drug
Who is being recruted

Asthma+11

+ Bronchial Diseases

+ Chronic Disease

From 18 to 55 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: October 2013
See protocol details

Summary

Principal SponsorMylan Pharma UK Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2013

Actual date on which the first participant was enrolled.

Study drug will be administered through the inhaled route to healthy subjects in single doses (three inhalations, i.e. total dose 750 µg FP and 150 µg SAL). Each subject will receive the following treatments in a random order: A. MGR001 B. Seretide™ Accuhaler™ C. Advair® Diskus® There will be a wash out of 3 7 days between treatment periods. Pharmacokinetics will be assessed by the measurement of plasma concentrations of FP and SAL over the 48 hours following dosing. Adverse Events will be collected throughout the study.

Official TitleA Bioequivalence Study to Assess the Systemic Exposure of Fluticasone Propionate and Salmeterol Administered as a Fixed Dose Combination From Different Dry Powder Inhalers in Healthy Subjects
NCT02215122
Principal SponsorMylan Pharma UK Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesChronic DiseaseHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory HypersensitivityRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

Criteria

4 inclusion criteria required to participate
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.
16 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Worldwide Clinical Trials Early Phase Services

San Antonio, United StatesOpen Worldwide Clinical Trials Early Phase Services in Google Maps
CompletedOne Study Center