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Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus

NCT01766843 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-01-03

No results posted yet for this study

Summary

The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.

Conditions

Interventions

DRUG

Seretide Diskus and charcoal

2 inhalations as a single dose

DRUG

Seretide Diskus

2 inhalations as a single dose

DRUG

SF Easyhaler and charcoal

2 inhalations as a single dose

DRUG

SF Easyhaler

2 inhalations as a single dose

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Leena Mattila, MD, PhD · Orion Corporation, Orion Pharma

  • Maria Sokka · IRW Consulting

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Finland

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 NCT01766843 on ClinicalTrials.gov