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Corticosteroid

A Bioequivalence Study Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions

Phase 1
Waitlist Available
Led By Chrysoula Doxani, MD, MSc, PhD
Research Sponsored by Respirent Pharmaceuticals Co Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder

Eligible Conditions
  • Asthma
  • Bioequivalence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC(0-t)
Cmax
Secondary study objectives
AUC0-∞
Residual Area
Tmax
+2 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Test ProductExperimental Treatment1 Intervention
Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals
Group II: Reference ProductActive Control1 Intervention
FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Becro Ltd.Industry Sponsor
18 Previous Clinical Trials
1,460 Total Patients Enrolled
6 Trials studying Asthma
1,088 Patients Enrolled for Asthma
Respirent Pharmaceuticals Co Ltd.Lead Sponsor
19 Previous Clinical Trials
1,911 Total Patients Enrolled
7 Trials studying Asthma
1,539 Patients Enrolled for Asthma
Chrysoula Doxani, MD, MSc, PhDPrincipal InvestigatorBecro Ltd.
5 Previous Clinical Trials
156 Total Patients Enrolled
2 Trials studying Asthma
54 Patients Enrolled for Asthma
~12 spots leftby Dec 2025
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