NCT05667818

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

An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Single Oral Dose Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets, EQ 5mg Base of Overseas Pharmaceuticals Ltd., China and Norvasc®(Amlodipine Besylate) Tablets, 5mg of Pfizer Laboratories Div. Pfizer Inc., in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions

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

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.

Detailed description

A single-center, randomized, open, two-cycle, double-cross, fasting experimental design method was adopted. All subjects must sign an informed consent form before taking part in the trial. Physical examination was conducted from the 14th day to the 1st day after administration, and the subjects the investigatorsre randomly assigned to one of the two sequential groups (T-R group and R-T group) according to the ratio of 1:1. That is, in the first cycle, 8 subjects in group T took one tablet of test preparation (amlodipine besylate controlled-release tablet, specification: 5mg) orally on an empty stomach; Group r: 8 subjects took one tablet of control preparation (amlodipine besylate tablet, Luohuoxi, specification: 5 mg) orally on an empty stomach, and about 240 ml of warm water was taken. Cross administration after 14 days. On the morning of taking medicine, after the collection of blank blood samples, group T took one tablet of the test preparation (amlodipine besylate controlled-release tablets) orally; In group R, the oral control preparation (amlodipine besylate tablet) was taken with about 240 ml warm water. After 4 hours of administration, the standard meal was taken uniformly. Drinking water (except 240 ml water for medicinal purposes) is prohibited within 1 h before and 1 h after administration, and a unified diet is required during the experiment. The cleaning period was 14 days, and after 14 days, the drugs the investigatorsre administered in a cross way. PK blood collection and blood sample treatment: 0 h before administration (within 1.0 h before administration) and 1.0 h, 2.0 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、14.0 h、16.0 h、24.0 h、36.0 h、48.0 h、72.0 h、96.0 h、144.0 h、168.0 h, a total of 27 time points to collect upper limb venous blood. 0 h before administration (within 1.0 h before administration) and 6.0± 0.5 h、12.0± 0.5 h、24.0±1.0 h、48.0±1.0 h、72.0±1.0 h、96.0±1.0 h、144.0±1.0 h、168.0±1.0 h after administration. The operating procedure of the second cycle is the same as that of the first cycle. In the second cycle, on the day after the sampling, the subjects need physical examination, vital signs examination, electrocardiogram and laboratory examination. During the study, the investigators should observe and ask the subjective feelings of the subjects and the possible adverse reactions and events during the experiment. If the subject has AE during the trial, the researcher should try to follow up until the adverse events are relieved, or return to the screening level, or the subject's condition is stable.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	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. Take one tablet once a day.
DRUG	Amlodipine besylate controlled-release tablets	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.

Timeline

• Start date: 2023-01-28
• Primary completion: 2023-02-28
• Completion: 2023-03-10
• First posted: 2022-12-29
• Last updated: 2023-01-04

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study