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A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade

NCT04124094 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-07-07

No results posted yet for this study

Summary

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

Conditions

  • Bioequivalence

Interventions

DRUG

Test Product (Fluticasone propionate and salmeterol xinafoate inhalation powder/Respirent Pharmaceuticals)

Fluticasone propionate 100 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals

DRUG

Reference Product (SERETIDE DISKUS® 100/50 inhalation powder/GSK)

2 inhalations in one study period

OTHER

Activated Charcoal suspension

oral suspension before and after inhalation of study Investigational Products

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
2019-10-01
Primary Completion
2019-10-25
Completion
2020-06-09

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 NCT04124094 on ClinicalTrials.gov