drugset / Trial / NCT05614037
Felodipine Controlled Release Tablets and Felodipine Sustained Release Tablets in Healthy Subjects Under Fasting State Comparative Pharmacokinetic Study
Phase 1
Unknown
16 enrolled
Overseas Pharmaceuticals, Ltd.
Guangzhou Kangqi Medical Technology Co., LTD · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Felodipine | Small molecule | 5 mg | Oral |