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NCT04494321

A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block

A Single-Dose, Randomized, Open-Label, Two-Treatment, Three-Period, Three-Sequence, Three-Way Crossover, Partial Replicate, Oral BE Pivotal Study of SYN010 HFA 160/4.5 Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block
Intech Biopharm Ltd.·Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Asthma,COPD
Drug/Device/Intervention
Budesonide
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Intech Biopharm Ltd.
Location
New Taipei City, Taiwan
Timeline & enrollment
Phase
Phase 1
Start date
Jun 19, 2017
End date
Nov 17, 2017
Enrollment
99 participants
Primary outcome

Area Under Curve (AUC),Maximum plasma concentration (Cmax)

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 without charcoal block.

ICD-10 classifications
AsthmaAsthma, unspecifiedNonallergic asthmaMixed asthmaOther chronic obstructive pulmonary disease
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04494321
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04494321 through Pure Global AI's free database. This Phase 1 trial is sponsored by Intech Biopharm Ltd. and is currently Completed. The study focuses on Asthma,COPD. Target enrollment is 99 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.