Overview

An Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets,China in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions

Status:
Not yet recruiting

Trial end date:
2023-01-10

Target enrollment:

Participant gender:

Summary

Amlodipine Besylate Controlled-release Tablets in Healthy Volunteers in a Randomized, Open, Two-cycle, Double-cross, Fasting State Comparative Pharmacokinetic Study. Major objective: Taking amlodipine besylate controlled-release tablets (specification: 5 mg) developed by Overseas Pharmaceuticals, Ltd. as the test preparation and amlodipine besylate tablets (trade name: Luohuoxi, specification: 5 mg) produced by Pfizer Inc. as the control preparation, the pharmacokinetics parameters of the single oral administration test preparation and the control preparation in China healthy volunteers were investigated and compared in an fasting state. Secondary objective: To evaluate the safety of single oral administration of test preparation and control preparation in China healthy volunteers on an empty stomach.

Phase:

Phase 1

Details

Lead Sponsor:

Overseas Pharmaceuticals, Ltd.

Collaborator:

Guangzhou Health Start Pharmaceutical Techology Co.,Ltd

Treatments:

Amlodipine
Norfloxacin