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A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block - Trial NCT04494321

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.

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NCT04494321
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov • NCT04494321
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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

Study Focus

Asthma,COPD

Budesonide

Interventional

drug

Sponsor & Location

Intech Biopharm Ltd.

New Taipei City, Taiwan

Timeline & Enrollment

Phase 1

Jun 19, 2017

Nov 17, 2017

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

Asthma
Asthma, unspecified
Nonallergic asthma
Mixed asthma
Other chronic obstructive pulmonary disease

Data Source

ClinicalTrials.gov

NCT04494321

Non-Device Trial