deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT03657550

Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects

Randomized Open-label Single-Dose Two-Way Crossover Study to Assess the Relative Bioavailability of 5mg Levamlodipine Tablet vs. 10mg Amlodipine Besylate Tablet in Healthy Subjects Followed by a Phase to Study Food Effect on the PK of Levamlodipine

Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

Conditions Hypertension
Updated 7 times since 2018 Last updated: Sep 9, 2021 Started: May 31, 2018 Primary completion: Sep 6, 2018 Completion: Sep 6, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Hypertension, this trial is completed. The trial is conducted by CSPC Ouyi Pharmaceutical Co., Ltd. and has accumulated 7 data snapshots since 2018. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Status Flow

~Oct 2018 – ~Dec 2018 · 2 months · monthly snapshotRecruiting~Dec 2018 – ~May 2019 · 5 months · monthly snapshotCompleted~May 2019 – ~Jan 2021 · 20 months · monthly snapshotCompleted~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotCompleted~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

7 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. May 2019 — Jan 2021 [monthly]

    Completed PHASE1

Show 2 earlier versions
  1. Dec 2018 — May 2019 [monthly]

    Completed PHASE1

    Status: RecruitingCompleted

  2. Oct 2018 — Dec 2018 [monthly]

    Recruiting PHASE1

    First recorded

May 2018

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • CSPC Ouyi Pharmaceutical Co., Ltd.
  • Conjupro Biotherapeutics, Inc.
Data source: Conjupro Biotherapeutics, Inc.

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

Study Locations