deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT04124094

A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade

A Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study to Examine the Bioequivalence Between Fluticasone Propionate 100 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. SERETIDE DISKUS® 100/50 Inhalation Powder/GSK in Healthy Volunteers Under Fasting Conditions With Charcoal Blockade

Sponsor: Becro Ltd.

Conditions Bioequivalence
Updated 6 times since 2019 Last updated: Jul 5, 2020 Started: Oct 1, 2019 Primary completion: Oct 25, 2019 Completion: Jun 9, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Bioequivalence and is currently completed. Becro Ltd. leads this study, which shows 6 recorded versions since 2019 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Nov 2019 – ~Aug 2020 · 9 months · monthly snapshotRecruiting~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotCompleted~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 21 months · monthly snapshotCompleted

Change History

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

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Oct 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Oct 2021 [monthly]

    Completed PHASE1

  5. Aug 2020 — Jan 2021 [monthly]

    Completed PHASE1

    Status: RecruitingCompleted

Show 1 earlier version
  1. Nov 2019 — Aug 2020 [monthly]

    Recruiting PHASE1

    First recorded

Oct 2019

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Becro Ltd.
  • Respirent Pharmaceuticals Co Ltd.
Data source: Respirent Pharmaceuticals Co Ltd.

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

Study Locations