An Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets,China in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions

NCT05667818 | Unknown Phase 1 FDA Drug

• 1 other identifier: YYKQ-202210-2
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Amlodipine Besylate Controlled-release Tablets in Healthy Volunteers in a Randomized, Open, Two-cycle, Double-cross, Fasting State Comparative Pharmacokinetic Study. Major objective: Taking amlodipine besylate controlled-release tablets (specification: 5 mg) developed by Overseas Pharmaceuticals, Ltd. as the test preparation and amlodipine besylate tablets (trade name: Luohuoxi, specification: 5 mg) produced by Pfizer Inc. as the control preparation, the pharmacokinetics parameters of the single oral administration test preparation and the control preparation in China healthy volunteers were investigated and compared in an fasting state. Secondary objective: To evaluate the safety of single oral administration of test preparation and control preparation in China healthy volunteers on an empty stomach.

Conditions

Hypertension

Keywords

Hypertension; Healthy Volunteers; morning surge; Amlodipine Besylate

Outcome Measures

Primary Outcomes (3)

• Area under the curve from time zero to the time of the last quantifiable plasma

  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)

Amlodipine besylate controlled-release tablets

EXPERIMENTAL

Test preparation (T): amlodipine besylate controlled-release tablets Specification: 5 mg Batch No.: 22102501 Content: 100.9% Expiry date: October 24, 2024 Storage conditions: dark, sealed at room temperature. Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day.

Drug: Amlodipine besylate controlled-release tablets

Amlodipine besylate tablets (trade name: Norfloxacin ®）

ACTIVE COMPARATOR

Specification: 5 mg Batch No.: FX3445 Content: 100.2% Expiry date: January 2027 Storage conditions: dark and sealed Manufacturer: Pfizer Inc. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day.

Drug: Amlodipine besylate tablets (trade name: Norfloxacin ®）

Interventions

Amlodipine besylate tablets (trade name: Norfloxacin ®） DRUG

Specification: 5 mg Batch No.: FX3445 Content: 100.2% Expiry date: January 2027 Storage conditions: dark and sealed Manufacturer: Pfizer Inc. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day.

Amlodipine besylate tablets (trade name: Norfloxacin ®）

Amlodipine besylate controlled-release tablets DRUG

Test preparation (T): amlodipine besylate controlled-release tablets Specification: 5 mg Batch No.: 22102501 Content: 100.9% Expiry date: October 24, 2024 Storage conditions: dark, sealed at room temperature. Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day.

Amlodipine besylate controlled-release tablets

Eligibility Criteria

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

You may qualify if:

• Subjects fully understand the purpose, nature, method and possible adverse reactions of the trial, voluntarily serve as subjects, and sign an informed consent form before any research procedure.
• Healthy subjects over the age of 18 (including the age of 18) can be both male and female.
• Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; Body mass index (BMI) is in the range of 19.0\~26.0 kg/m2 (including the critical value).
• From the signing of the informed consent form to the end of the study, there was no birth plan and voluntary adoption of appropriate and effective contraceptive measures, and there was no sperm or egg donation plan.
• Subjects who can communicate well with researchers and understand and comply with the requirements of this study

You may not qualify if:

• Allergic constitution, or a history of food or drug allergy or other allergic diseases (asthma, urticaria, eczema dermatitis, etc.); Or allergic to any component of amlodipine besylate.
• Have a history of hypotension, or have a history of aortic stenosis or coronary artery occlusion.
• Those who have poor condition of blood vessel puncture, or can not tolerate vein puncture, or have a history of needle and blood sickness.
• There are cardiovascular, blood, liver, kidney, endocrine, respiratory, digestive, nervous, mental, immune, skin and metabolic disorders and other system diseases that researchers think are clinically significant, or there is a chronic or serious history of these diseases; Or there is a history of surgery that may affect drug absorption and metabolism.
• Those with abnormal physical examination, vital sign examination, 12 lead ECG and laboratory examination, and those with clinical significance judged by the research doctor.
• Human immunodeficiency virus (HIV) antibody, or hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (Anti TP) test results are positive.
• Pregnant women, lactating women, or women of childbearing age have unprotected sexual behavior within 14 days before the planned administration, or the pregnancy test results are positive.
• Those vaccinated within 3 months before screening (except for COVID-19 vaccine), or those vaccinated with COVID-19 vaccine within 1 week before screening, or those who plan to vaccinate any vaccine during the trial or within 1 week after the end of the study;
• Or blood donation/blood loss ≥ 400 mL or blood transfusion or use of blood products within 3 months before screening, or blood donation (including blood components) planned during the test or within 3 months after the test.
• Previous medication:
• Those who have a history of drug abuse or are positive for drug screening and have used drugs 6 months before screening, including MDMA (ecstasy), methamphetamine (methamphetamine), ketamine, morphine, tetrahydrocannabinol acid (cannabis).
• Drugs that inhibit or induce liver metabolism of drugs (such as inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) were used within 30 days before the first administration; Or 14 days before administration, any other drugs including prescription drugs, over-the-counter drugs, functional vitamins, health products or Chinese herbal medicine were used.
• Eating, smoking and drinking:
• People with dysphagia, or those who have special requirements for diet and cannot accept a unified diet.
• Those who used to drink too much caffeinated food or drink (such as coffee, strong tea, cola, chocolate, etc.) for a long time (more than 8 cups a day, 1 cup=250 mL), or take caffeinated food or drink within 72 hours before taking the drug for the first time, or can not be interrupted during the test.

Sponsors & Collaborators

• Overseas Pharmaceuticals, Ltd.: lead
• Guangzhou Health Start Pharmaceutical Techology Co.,Ltd: collaborator

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangdong, Guangzhou, 510280, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Dr. Huaihan Cai, Director of Medical Affairs

CONTACT

+8618352616957; caihuaihan@overseaspharm.com

Dr.shuai he, Doctor of pharmacy

CONTACT

+8618925092493; hs43555@163.com

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): amlodipine besylate controlled-release tablets Specification: 5 mg Batch No.: 22102501 Content: 100.9% Expiry date: October 24, 2024 Storage conditions: dark, sealed at room temperature. Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Overseas Pharmaceuticals, Ltd. Reference preparation (R): amlodipine besylate tablets (trade name: Norfloxacin ®） Specification: 5 mg Batch No.: FX3445 Content: 100.2% Expiry date: January 2027 Storage conditions: dark and sealed Manufacturer: Pfizer Inc. Provider: Overseas Pharmaceuticals, Ltd.

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 29, 2022
• Study Start: January 28, 2023
• Primary Completion: February 28, 2023
• Study Completion: March 10, 2023
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)