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A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. ADVAIR DISKUS® in Healthy Volunteers

NCT03751202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-12-28

No results posted yet for this study

Summary

Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder

Conditions

  • Bioequivalence

Interventions

DRUG

Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg

2 inhalations of Test and Reference product in each study period

DRUG

ADVAIR DISKUS

2 inhalations of Test and Reference product in each study period

Sponsors & Collaborators

  • Becro Ltd.

    collaborator INDUSTRY

  • Respirent Pharmaceuticals Co Ltd.

    lead INDUSTRY

Principal Investigators

  • Ioannis Stefanidis, Professor · University of Larissa School of Medicine

  • Chrysoula Doxani, MD, MSc, PhD · Becro Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2018-12-11
Completion
2018-12-11
FDA Drug
Yes

Countries

  • Greece

Study Locations

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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 NCT03751202 on ClinicalTrials.gov