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NCT03657550 · ClinicalTrials.gov registry record · Phase 1
Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects
A Phase 1 study, sponsored by Conjupro Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03657550: Completed Phase 1 study, sponsored by Conjupro Biotherapeutics.
NCT03657550 is a Phase 1 study that has completed, run by Conjupro Biotherapeutics. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03657550, a Phase 1 study, has completed, sponsored by Conjupro Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This study are (1) to assess the relative bioavailability (BA) of a single oral dose of either 5 mg of Levamlodipine Maleate Tablets from CSPC or 10 mg of Amlodipine Besylate Tablet (NORVASC®) from Pfizer Inc. under fasting condition in male and female healthy subjects; and (2) to evaluate food effect on the PK profile of Levamlodipine Maleate Tablets from CSPC.
Primary Outcome
Plasma concentration of study drugs will be measured at all the time points.
Interventions
- DRUG Levamlodipine, Amlodipine
- DRUG Amlodipine, Levamlodipine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-05-31 |
| Est. Completion | 2018-09-06 |
| Phase | Phase 1 |
What the finished NCT03657550 record still lists
NCT03657550 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Levamlodipine, Amlodipine is the first listed.
NCT03657550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03657550 about?
NCT03657550 is a clinical study titled "Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects". This study are (1) to assess the relative bioavailability (BA) of a single oral dose of either 5 mg of Levamlodipine Maleate Tablets from CSPC or 10 mg of Amlodipine Besylate Tablet (NORVASC®) from Pfizer Inc. under fasting condition in male and female healthy subjects; and (2) to evaluate food effe...
What is the current status of trial NCT03657550?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-05-31. Estimated completion is 2018-09-06.
What interventions are being tested in trial NCT03657550?
The interventions under investigation include: Levamlodipine, Amlodipine (DRUG), Amlodipine, Levamlodipine (DRUG).
Who is sponsoring clinical trial NCT03657550?
This trial is sponsored by Conjupro Biotherapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03657550's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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