NCT05614037 - Felodipine Controlled Release Tablets and Felodipine Sustained Release Tablets in Healthy Subjects Under Fasting State Comparative Pharmacokinetic Study | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 28, 2022

Primary Completion Date

November 20, 2022

Study Completion Date

March 30, 2023

Conditions

Hypertension

Interventions

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.

Trial Locations (1)

523000

Clinical Trial Centre of Dongguan Kanghua Hospital, Dongguan