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Study identifier: NCT04912596 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma

Condition: Mild Asthma  ·  Sponsor: Intech Biopharm Ltd.

PhaseNA
Planned participants148
Who can joinAll sexes, 20 Years to 65 Years
Healthy volunteersNo

About this study

The objective of this study is to evaluate the pharmacodynamic (PD) bioequivalence (BE) of albuterol inhalers, test formulation: Albuterol Sulfate HFA inhalation aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation and reference formulation: ProAir HFA (albuterol sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation manufactured by two different manufacturers using methacholine bronchoprovocation challenge test in patients with stable mild asthma.

This description comes directly from the study's public registry record.

Talk to the study team

Jasmine Kuo  ·  +886-2-7721-8877  ·  jasmine.i199@intechbiopharm.com

Always discuss trial participation with your own doctor first.

Locations (12)

Dr. Jivraj Mehta Smarak Health FoundationAhmedabad, IndiaNot Yet Recruiting
KLEs Dr Prabhakar Kore Hospital & MRCBelagāve, IndiaNot Yet Recruiting
NRS Medical College and HospitalKolkata, IndiaNot Yet Recruiting
Medical College and HospitalKolkata, IndiaNot Yet Recruiting
Aakash Healthcare Super Specialty HospitalNew Delhi, IndiaNot Yet Recruiting
Pimpri Chinchwad Municipal Corporation Post Graduate Institute Yashwantrao Chavan Memorial HospitalPune, IndiaNot Yet Recruiting
Kothrud HospitalPune, IndiaNot Yet Recruiting
Ashirwad Hospital and Research CentreUlhasnagar, IndiaNot Yet Recruiting
Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanRecruiting
Tamshui Mackay Memorial HospitalNew Taipei City, TaiwanRecruiting
Taipei Medical University HospitalTaipei, TaiwanRecruiting
Shin Kong Wu Ho-Su Memorial HospitalTaipei, TaiwanRecruiting

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Source record: clinicaltrials.gov/study/NCT04912596