Overview

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

Status:
Completed
Trial end date:
2018-09-06
Target enrollment:
Participant gender:
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 (NORVASCĀ®) 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.
Phase:
Phase 1
Details
Lead Sponsor:
Conjupro Biotherapeutics
Conjupro Biotherapeutics, Inc.
Collaborator:
CSPC Ouyi Pharmaceutical Co., Ltd.
Treatments:
Amlodipine
Maleic acid
Niacin