NCT05614037

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

Felodipine Controlled Release Tablets and Felodipine Sustained Release Tablets in Healthy Subjects Under Fasting State: Single Dose, Randomized, Open, 2-treatment，2-period，Crossover Comparative Pharmacokinetic Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Overseas Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The subjects were randomly assigned in a 1:1 ratio to one of two sequential administration groups (group T-R, group R-T). In the first cycle, 8 subjects took the test formulation (T) 5 mg/tablet by fasting, and the other 8 subjects took the reference formulation (R) 5 mg/tablet by fasting, with about 240 mL warm water. The drug was crossed over after 14 days. Phase I trial site pharmacists assigned study drugs to each phase according to the randomization list. Sixteen healthy subjects were randomly divided into two groups, T-R group and R-T group, with 8 cases in each group. The enrolled subjects entered the phase I observation room one day before the administration of each cycle, and were required to fast for more than 10 hours from the day before to the morning of the administration. After a blank blood sample was collected on the morning of administration, the study drug was administered in the fasting state. The standard meal was taken 4 hours after administration. Each week was performed at 0 h before administration (within 1.5 h before administration) and 0.5 h, 1.0 h, 1.5 h, 2.0 h, 2.5 h, 3.0 h, 3.5 h, 4.0 h, 4.5 h, 5.0 h, 5.5 h, 6.0 h, 6.5 h, 7.0 h, 7.5 h, 8.0 h, 8.5 h, 9.0 h, 10.0 h, 12.0 h, 24.0 h, 48.0 h, 72.0 h, a total of 24 blood sampling points were collected from the upper limb vein. Vital signs (including body temperature (frontal temperature), pulse and blood pressure) were measured at 0 h before administration (within 1.5 h before administration) and 4.0± 0.5 h, 8.0± 0.5 h, 24.0± 1.0 h, 48.0± 1.0 h and 72.0± 1.0 h after administration. The operation procedure of the second cycle is the same as that of the first cycle. In the second cycle, the subjects were required to take physical examination, vital signs examination, electrocardiogram and laboratory examination on the day after the end of sampling. If a subject has an AE during the trial, the investigator should try to follow the subject until the adverse event resolves, or returns to the screening level, or the subject's condition is stable.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Felodipine sustained release tablets (trade name: plendil®)	Reference preparation (R) : Felodipine sustained release tablets (trade name: plendil ®) Specification: 5 mg Batch number: 2204 a11 Content: 99.1% Valid until March 2025 Storage conditions: below 25℃ Manufacturer: AstraZeneca AB Supplier: Overseas Pharmaceuticals, Ltd. Usage: Oral, 1 tablet at a time, once a day. Take it before bed and swallow it with water. Do not break, press or chew the pill.
DRUG	Felodipine Controlled Release Tablets	Test preparation (T) :Felodipine Controlled Release Tablets Specification: 5 mg Batch number: 22090301 Content: 100.8% Valid until: September 2024 Storage conditions: sealed, room temperature (10\~30℃) Manufacturer: Overseas Pharmaceuticals, Ltd. Supplier: Overseas Pharmaceuticals, Ltd. Usage: Oral, 1 tablet at a time, once a day. Take it before bed and swallow it with water. Do not break, press or chew the pill.

Timeline

• Start date: 2022-10-28
• Primary completion: 2022-11-20
• Completion: 2023-03-30
• First posted: 2022-11-14
• Last updated: 2023-02-01

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study