deltatrials
Completed NA INTERVENTIONAL 2-arm NCT04803734

Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions

A Randomized, Single-dose, Open-label, Two-way Crossover Pivotal Study to Assess the Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) in Healthy Volunteers Under Fasting Conditions

Sponsor: Intech Biopharm Ltd.

Conditions Healthy
Updated 7 times since 2021 Last updated: Mar 4, 2024 Started: Mar 19, 2021 Primary completion: May 10, 2021 Completion: May 14, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04803734, this NA trial focuses on Healthy and remains completed. Sponsored by Intech Biopharm Ltd., it has been updated 7 times since 2021, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Sep 2022 · 12 months · monthly snapshotActive Not Recruiting~Sep 2022 – ~Oct 2023 · 13 months · monthly snapshotCompleted~Oct 2023 – ~Apr 2024 · 6 months · monthly snapshotCompleted~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed NA

  2. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  3. Apr 2024 — Jul 2024 [monthly]

    Completed NA

  4. Oct 2023 — Apr 2024 [monthly]

    Completed NA

  5. Sep 2022 — Oct 2023 [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

Show 2 earlier versions
  1. Sep 2021 — Sep 2022 [monthly]

    Active Not Recruiting NA

    Status: Not Yet RecruitingActive Not Recruiting

  2. Apr 2021 — Sep 2021 [monthly]

    Not Yet Recruiting NA

    First recorded

Mar 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Intech Biopharm Ltd.
Data source: Intech Biopharm Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations