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A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers

NCT04564456 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-01-20

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/Respirent

2 inhalations of Test oproduct in one study period

DRUG

ADVAIR DISKUS® 500/50

2 inhalations Reference product in one study period

Sponsors & Collaborators

  • Becro Ltd.

    collaborator INDUSTRY

  • Respirent Pharmaceuticals Co Ltd.

    lead INDUSTRY

Principal Investigators

  • Ioannis Stefanidis, Professor · University of Thessaly Department of Medicine

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
2020-09-22
Primary Completion
2020-10-31
Completion
2020-12-31
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 NCT04564456 on ClinicalTrials.gov