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A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers With Charcoal Block

NCT02850484 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2016-08-01

No results posted yet for this study

Summary

The objective of this pivotal study is to evaluate the relative bioavailability of SYN010 HFA Inhaler and Symbicort 160/4.5μg in healthy volunteers with charcoal block.

Conditions

  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Budesonide

Inhaled corticosteroid

DRUG

Formoterol

Long Acting Beta Agonist (LABA)

Sponsors & Collaborators

  • Intech Biopharm Ltd.

    lead INDUSTRY

Principal Investigators

  • Wen 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
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

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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 NCT02850484 on ClinicalTrials.gov