drugset / Trial / NCT03657550
Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects
Phase 1
Completed
36 enrolled
Conjupro Biotherapeutics, Inc.
CSPC Ouyi Pharmaceutical Co., Ltd. · collab
RandomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2018-05-31
- Primary completion
- 2018-09-06
- Completion
- 2018-09-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 10 mg | Oral |
| Subject | S-amlodipine | Unknown | 5 mg | Oral |