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Bioequivalence Study for Fluticasone Propionate 100 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers

NCT05697003 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-03-09

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 1000 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals

2 inhalations in one study period

DRUG

ADVAIR DISKUS 100/50

2 inhalations in one study period

Sponsors & Collaborators

  • Becro Ltd.

    collaborator INDUSTRY

  • Respirent Pharmaceuticals Co Ltd.

    lead INDUSTRY

Principal Investigators

  • 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
2023-02-17
Primary Completion
2023-03-31
Completion
2023-05-01
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 NCT05697003 on ClinicalTrials.gov