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Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers Without Charcoal Block

NCT02466347 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-07-26

No results posted yet for this study

Summary

The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers without charcoal block.

Conditions

  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Fluticasone propionate

Inhaled corticosteroid, pMDI

DRUG

Salmeterol (as xinafoate)

Long Acting Beta-agonist (LABA), pMDI

Sponsors & Collaborators

  • Intech Biopharm Ltd.

    lead INDUSTRY

Principal Investigators

  • W K Chang, M.D · Clinical Pharmacology Unit of Mackay Memorial Hospital Tamshui Branch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Taiwan

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 NCT02466347 on ClinicalTrials.gov