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

NCT02215122 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-07

No results posted yet for this study

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

Interventions

DRUG

MGR001

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

DRUG

Advair® Diskus®

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

DRUG

Seretide™ Accuhaler™

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

Sponsors & Collaborators

  • Mylan Pharma UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Jon Ward · Mylan Pharma UK Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02215122 on ClinicalTrials.gov