deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT01177293

Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules

Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To 10 Mg Amlodipine Besylate Capsules, Manufactured By Pfizer France Under Fasted Conditions

Sponsor: Aurobindo Pharma Ltd

Updated 8 times since 2017 Last updated: Jan 26, 2021 Started: Mar 31, 2010 Primary completion: Jun 30, 2010 Completion: Jun 30, 2010
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 Healthy Volunteers and is currently completed. Aurobindo Pharma Ltd leads this study, which shows 8 recorded versions since 2010 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshotCompleted~Sep 2018 – ~Jan 2021 · 28 months · monthly snapshotCompleted~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshotCompleted~Feb 2021 – ~Jul 2024 · 41 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

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

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Feb 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Feb 2021 [monthly]

    Completed PHASE1

  5. Sep 2018 — Jan 2021 [monthly]

    Completed PHASE1

Show 3 earlier versions
  1. Jun 2018 — Sep 2018 [monthly]

    Completed PHASE1

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Mar 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Aurobindo Pharma Ltd
  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
  • Trident Life Sciences Ltd.
Data source: Pfizer

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

Study Locations