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

NCT05614037 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-02-01

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Guangzhou Kangqi Medical Technology Co., LTD

    collaborator UNKNOWN

  • Overseas Pharmaceuticals, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2022-11-20
Completion
2023-03-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05614037 on ClinicalTrials.gov