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Pooled Analysis FP_SX_250_50

NCT04790838 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 82

Last updated 2021-03-10

No results posted yet for this study

Summary

A pooled analysis of three bioequivalence studies conducted for Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (Test, T) vs ADVAIR DISKUS® 250/50 mcg inhalation powder/GSK (Reference, R) were conduted.

Conditions

Interventions

DRUG

Test

2 inhalations of Test and Reference product in each study period

DRUG

Reference

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

  • Elias Zintzaras, Professor · Becro Ltd.

Eligibility

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

Timeline & Regulatory

Start
2019-06-02
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • Greece

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 NCT04790838 on ClinicalTrials.gov