Completed PHASE1 INTERVENTIONAL 2-arm NCT03751202

A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. ADVAIR DISKUS® in Healthy Volunteers (BREATH-PK500)

A Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence 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

Sponsor: Becro Ltd.

Conditions Bioequivalence

Interventions ADVAIR DISKUS Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg

Updated 6 times since 2018 Last updated: Dec 27, 2018 Started: Nov 20, 2018 Primary completion: Dec 11, 2018 Completion: Dec 11, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03751202, this PHASE1 trial focuses on Bioequivalence and remains completed. Sponsored by Becro Ltd., it has been updated 6 times since 2018, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Oct 2021 — Jul 2024 [monthly]

Completed PHASE1
Jan 2021 — Oct 2021 [monthly]

Completed PHASE1
Jan 2019 — Jan 2021 [monthly]

Completed PHASE1

Status: Recruiting → Completed

▶ Show 1 earlier version

Dec 2018 — Jan 2019 [monthly]

Recruiting PHASE1

First recorded

Nov 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Becro Ltd.
Respirent Pharmaceuticals Co Ltd.

Data source: Respirent Pharmaceuticals Co Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Larissa, Greece