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NCT03820180

A Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers

Completed Phase 1 Last updated 27 March 2019
What this trial tests

Phase 1 trial testing Test Product in Bioequivalence in 34 participants. Completed in 19 February 2019.

Timeline
23 January 2019
Primary endpoint
12 February 2019
19 February 2019

Quick facts

Lead sponsorRespirent Pharmaceuticals Co Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposeother
Enrollment34
Start date23 January 2019
Primary completion12 February 2019
Estimated completion19 February 2019
Sites1 location across Greece

Drugs / interventions tested

Conditions studied

Sponsor

Respirent Pharmaceuticals Co Ltd. — full company profile →

Who can join

Adults 18 to 60, any sex, with Bioequivalence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Test Product

Trials testing the same drug.

Other recruiting trials for Bioequivalence

Currently open trials in the same condition.

Other Respirent Pharmaceuticals Co Ltd. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03820180.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing