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

NCT05614037 | Unknown Phase 1 FDA Drug

• 1 other identifier: YYKQ-202207
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension

Keywords

Felodipine; Hypertension; Healthy Volunteers; morning surge

Outcome Measures

Primary Outcomes (3)

• Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)

  The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-last within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.

  1 month

• Area under the curve from time zero to infinity (AUC0-inf)

  The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of AUC0-inf within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.

  1 month

• Peak concentration at each treatment period (Cmax,tp)

  The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of Cmax,tp within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.

  1 month

Secondary Outcomes (4)

• Peak concentration of the first dosing (Cmax)

  1 month

• Time to reach peak concentration of the first dosing (Tmax)

  1 month

• Terminal half-life (T1/2)

  1 month

• Mean residence time (MRT)

  1 month

Study Arms (2)

Felodipine Controlled Release Tablets

EXPERIMENTAL

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.

Drug: Felodipine sustained release tablets (trade name: plendil®)

Felodipine Modified-release Tablets (trade name:plendil ®)

ACTIVE COMPARATOR

Reference preparation (R) : Felodipine Modified-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

Interventions

Felodipine sustained release tablets (trade name: plendil®) DRUG

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.

Felodipine Controlled Release Tablets

Felodipine Controlled Release Tablets DRUG

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.

Felodipine Modified-release Tablets (trade name:plendil ®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is fully aware of the purpose, nature, method and possible adverse reactions of the study, voluntarily acts as a subject, and signs informed consent prior to the commencement of any study procedure.
• Healthy subjects (male or female) aged 18 years or older.
• Male weight ≥50.0 kg, female weight ≥45.0 kg; Body mass index (BMI) was in the range of 19.0 to 26.0 kg/m2 (including the critical value).
• From the signing of informed consent to 6 months after the end of the study, they had no fertility plan, voluntarily took appropriate and effective contraceptive measures, and had no sperm and egg donation plan.
• The subjects were able to communicate well with the researchers and understood and complied with the requirements of the study.

You may not qualify if:

• Allergic disposition or a history of food or drug allergy or other allergic diseases (asthma, urticaria, eczema dermatitis, etc.) that researchers deem clinically significant; Or allergic to any component of felodipine.
• Patients with poor vascular puncture conditions, or who cannot tolerate venipunction, or who have a history of fainting needles and fainting blood.
• Patients with gingivitis and periodontitis.
• Previous history of compensatory heart failure, acute myocardial infarction, unstable angina pectoris.
• lactose intolerance, or galactose intolerance, lactase deficiency, glucose-galactose malabsorption.
• Patients with confirmed hypotension or history of postural hypotension.
• The presence of cardiovascular, blood, liver, kidney, endocrine, respiratory, digestive, nervous, psychiatric, immune, skin, metabolic disorders and other systemic diseases considered clinically significant by researchers, or a chronic or severe history of these diseases; Or a history of surgery that may affect drug absorption and metabolism.
• Physical examination, vital signs examination, 12-lead electrocardiogram and laboratory examination were abnormal and clinically significant as judged by the study physician.
• Positive for human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or treponema pallidum antibody (Anti-TP).
• Pregnant women, breastfeeding women, or women of childbearing age who have unprotected sex or pregnancy test positive within 14 days before the planned dose.
• Those who received vaccines (other than COVID-19 vaccine) within 3 months prior to screening, or who received COVID-19 vaccine within 1 week prior to screening, or who plan to receive any vaccines during the trial or within 1 week after the study ends;
• Those who have donated blood/lost blood ≥400 mL in the 3 months prior to screening or who have received blood transfusions or used blood products, or who intend to donate blood (including blood components) during or 3 months after the end of the trial.
• Previous drug use:
• Those with a history of drug abuse or who have tested positive for drugs and used drugs in the six months prior to screening, including methylenedioxymethamphetamine (ecstasy), methamphetamine (meth), ketamine, morphine, and THC (marijuana).
• Drugs that inhibit or induce liver metabolism of drugs (such as inducers: barbiturates, carbamazepine, phenytoin, rifampicin, St. John's wort, etc.) were used within 28 days before the initial administration; Inhibitors: cimetidine, cyclosporine, pyrrole antifungal drugs (itraconazole, ketoconazole), macrolides antibiotics (erythromycin), HIV protease inhibitors, etc.); Or any other medication including prescription drugs, over-the-counter drugs, functional vitamins, health products, or Chinese herbs used in the 14 days prior to administration.

Sponsors & Collaborators

• Overseas Pharmaceuticals, Ltd.: lead
• Guangzhou Kangqi Medical Technology Co., LTD: collaborator

Study Sites (1)

Clinical Trial Centre of Dongguan Kanghua Hospital

Dongguan, Guangdong, 523000, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. Reference preparation (R) :Felodipine Modified-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.

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: October 28, 2022
• Primary Completion: November 20, 2022
• Study Completion: March 30, 2023
• Last Updated: February 1, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)