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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 is a Phase 1 study that has completed, run by Conjupro Biotherapeutics. The registered enrollment target is 36 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03657550
The ClinicalTrials.gov registry entry for NCT03657550 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Conjupro Biotherapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Levamlodipine, Amlodipine is the first listed.
NCT03657550 reports 0 study locations.
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.
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