drugset / Trial / NCT05614037

Felodipine Controlled Release Tablets and Felodipine Sustained Release Tablets in Healthy Subjects Under Fasting State Comparative Pharmacokinetic Study

NCT05614037

RandomizedCrossoverOpen-labelBasic science

Summary

Felodipine Controlled Release Tablets and Felodipine Modified-release Tablets in Healthy Subjects Under Fasting State: Single Dose, Randomized, Open, 2-treatment,2-period,Crossover Comparative Pharmacokinetic Study Main research objectives: Felodipine Controlled Release Tablets(strength: 5 mg) developed by Overseas Pharmaceuticals, Ltd., and Felodipine Modified-release Tablets (strength: 5 mg) produced by AstraZeneca AB., trade name: The pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects under fasting state were investigated and compared. Secondary research objectives: To observe the safety of test preparation and reference preparation in healthy subjects.

Timeline

Start
2022-10-28
Primary completion
2022-11-20
Completion
2023-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Felodipine Small molecule 5 mg Oral

Indications