[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of levamlodipine besylate tablets in healthy Chinese subjects: two-formulation, two-sequence, two-period, crossover

主要目的：观察中国健康受试者在空腹/餐后状态下单次口服受试制剂苯磺酸左氨氯地平片（规格：5mg（按左氨氯地平计）；生产企业：湖南千金湘江药业股份有限公司）和参比制剂苯磺酸氨氯地平片（商品名：络活喜®；规格：10mg；持证商和生产企业：辉瑞制药有限公司）后的药代动力学特征，评价空腹/餐后状态下两种制剂的生物等效性。次要目的：观察受试制剂苯磺酸左氨氯地平片和参比制剂苯磺酸氨氯地平片（络活喜®）在中国健康受试者中的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation levamlodipine besylate tablets (specification: 5 mg (calculated as levamlodipine); manufacturer: Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.) and the reference preparation amlodipine besylate tablets (trade name: Norvasc®; specification: 10 mg; licensee and manufacturer: Pfizer Pharmaceuticals Co., Ltd.) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation levamlodipine besylate tablets and the reference preparation amlodipine besylate tablets (Norvasc®) in healthy Chinese subjects.

Start Date06 Aug 2024

Sponsor / Collaborator

Hunan Qianjin Xiangjiang Pharmaceutical Industry Co., Ltd.

CTR20242054 / RecruitingNot Applicable

中国健康受试者空腹及餐后口服苯磺酸左氨氯地平片单中心、开放、随机、单剂量、两周期、两序列、自身交叉设计的生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, self-crossover bioequivalence study of fasting and fed oral amlodipine besylate tablets in healthy Chinese volunteers

主要研究目的研究空腹和餐后状态下单次口服受试制剂苯磺酸左氨氯地平片（规格：5mg，广东万泰科创药业有限公司提供）与参比制剂苯磺酸氨氯地平片（络活喜®；规格：10mg；持证商：辉瑞制药有限公司）在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂苯磺酸左氨氯地平片和参比制剂苯磺酸氨氯地平片（络活喜®）后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation levamlodipine besylate tablets (specification: 5mg, provided by Guangdong Wantai Kechuang Pharmaceutical Co., Ltd.) and the reference preparation amlodipine besylate tablets (Norvasc®; specification: 10mg; licensee: Pfizer Pharmaceuticals Co., Ltd.) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary study objectives To evaluate the safety of the test preparation levamlodipine besylate tablets and the reference preparation amlodipine besylate tablets (Norvasc®) in healthy Chinese subjects in the fasting and fed state after a single oral administration.

Start Date09 Jul 2024

Sponsor / Collaborator

Guang Dong Wan Tai Ke Chuang Yao Ye You Xian Gong Si

CTR20241403 / CompletedNot Applicable

中国健康受试者空腹及餐后口服苯磺酸左氨氯地平片单中心、开放、随机、单剂量、两周期、两序列、自身交叉设计的生物等效性试验

主要研究目的研究空腹和餐后状态下单次口服受试制剂苯磺酸左氨氯地平片（规格：2.5mg，苏州东瑞制药有限公司提供）与参比制剂苯磺酸氨氯地平片（络活喜®；规格：5mg；持证商：辉瑞制药有限公司），在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂苯磺酸左氨氯地平片和参比制剂苯磺酸氨氯地平片（络活喜®）后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation levamlodipine besylate tablets (specification: 2.5mg, provided by Suzhou Dongrui Pharmaceutical Co., Ltd.) and the reference preparation amlodipine besylate tablets (Norvasc®; specification: 5mg; licensee: Pfizer Pharmaceuticals Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after fasting and fed oral administration. Secondary study objectives To evaluate the safety of the test preparation levamlodipine besylate tablets and the reference preparation amlodipine besylate tablets (Norvasc®) after a single oral administration in the fasting and fed state in healthy Chinese subjects.

Start Date22 May 2024

Sponsor / Collaborator

Suzhou Dawnrays Pharmaceutical Co., Ltd.

100 Clinical Results associated with Levamlodipine Besylate

100 Translational Medicine associated with Levamlodipine Besylate

100 Patents (Medical) associated with Levamlodipine Besylate

Literatures (Medical) associated with Levamlodipine Besylate

01 Dec 2020·BMC Pharmacology and ToxicologyQ4 · MEDICINE

Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: a single-dose and two-period crossover randomized study

Q4 · MEDICINE

ArticleOA

Author: Li, Xin ; Liu, Shuqin ; Ma, Yaping ; Cao, Yu ; Li, Ting ; Tao, Ye ; Gao, Xiaomeng ; Liu, Yanping ; Wang, Chenjing

AbstractBackgroundLevamlodipine, a calcium channel blocker, has been show act as a cardiovascular drug. To compare the pharmacokinetic parameters between levamlodipine (test formulation) at a single dose of 5 mg and amlodipine (reference formulation) at a single dose of 10 mg, the bioequivalence study was carried out.MethodsA single-dose randomized, open-label, two-period crossover study was designed in healthy Chinese subjects. 48 subjects were divided into fasted and fed groups equally. The subjects randomly received the test or reference formulations at the rate of 1:1. Following a 21-day washout period, the alternative formulations were received. The blood samples were collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 h later. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was applied to determine the plasma concentrations of levamlodipine. Adverse events were recorded.ResultsThe 90% confidence intervals (CIs) of the ratio of geometric means (GMRs) of Cmax, AUC0-t, and AUC0-∞ under both fasted and fed conditions were within the prespecified bioequivalence limits between 80 ~ 125%. Under fasted conditions, 24 subjects were enrolled and completed the study. The mean Cmax was (2.70 ± 0.49) ng/mL, AUC0-t was (141.32 ± 36.24) ng × h/mL and AUC0-∞ was (157.14 ± 45.65) ng × h/mL after a single dose of 5 mg levamlodipine. The mean Cmax was (2.83 ± 0.52) ng/mL, AUC0-t was (153.62 ± 33.96) ng × h/mL and AUC0-∞ was (173.05 ± 41.78) ng × h/mL after a single dose of 10 mg amlodipine. Under fed conditions, 24 subjects were enrolled and completed the study. The mean Cmax was (2.73 ± 0.55) ng/mL, AUC0-t was (166.93 ± 49.96) ng × h/mL and AUC0-∞ was (190.99 ± 70.89) ng × h/mL after a single dose of 5 mg levamlodipine. The mean Cmax was (2.87 ± 0.81) ng/mL AUC0-t was (165.46 ± 43.58) ng × h/mL and AUC0-∞ was (189.51 ± 64.70) ng × h/mL after a single dose of 10 mg amlodipine. Serious adverse event was not observed.ConclusionThe trial confirmed that levamlodipine at a single dose of 5 mg and amlodipine at a single dose of 10 mg were bioequivalent under both fasted condition and fed condition.Trial registrationCinicaltrials, NCT04411875. Registered 3 June 2020 - Retrospectively registered

01 Oct 2017·Int. Journal of Clinical Pharmacology and TherapeuticsQ4 · MEDICINE

Randomized, two-way crossover bioequivalence study of levamlodipine besylate tablets in healthy Chinese subjects

Q4 · MEDICINE

Article

Author: Li, Xiao-Min ; Li, Dai ; Xu, Su-Mei ; Li, Dan ; Wang, Yu-Lu ; Xu, Ping-Sheng

OBJECTIVEThe present bioequivalence study was designed to compare the newly-developed levamlodipine besylate 2.5-mg tablet (test) with that of its 2.5-mg marketed counterpart (reference) in healthy Chinese adult male volunteers.METHODSA single-dose, randomized, open-label, two-period, and two-treatment self-crossover study was conducted in healthy Chinese volunteers after informed consent was obtained. In each part of the study, the subjects were randomly assigned to receive the test or reference product (5 mg levamlodipine) in a 1 : 1 ratio, and then received the alternative product, following a 14-day washout period. Plasma levamlodipine concentrations were analyzed by liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters (noncompartmental model) were assessed with WinNonlin software. Analysis of variance (ANOVA) and FDA (USA) bioequivalence statistical criterion of 90% CI for 80 - 125% range (set at p ≤ 0.05) of geometric means ratios of test : reference product for C_max, AUC_0-t, and AUC_0-∞ were determined. Tolerability was assessed during the entire study period.RESULTSANOVA indicated that the period, sequence, and formulation had no significant effect on the PK parameters (p ≥ 0.05), although there was a statistically-significant difference between formulations in AUC_0-t (p ≤ 0.05). The test formulation was bioequivalent to the marketed formulation as the 90% CI for the ratio of geometric means of C_max (84.52 - 103.00%), AUC_0-t (87.49 - 98.23%), and AUC_0-∞ (84.30 - 103.25%) were within equivalence limits (80 - 125%) under fasting condition. No serious adverse events were found among the subjects.CONCLUSIONThis study confirmed that test and reference levamlodipine besylate tablets were bioequivalent under fasting condition. .

01 May 2016·Hypertension ResearchQ3 · MEDICINE

Effects of antihypertensive drugs losartan and levamlodipine besylate on insulin resistance in patients with essential hypertension combined with isolated impaired fasting glucose

Q3 · MEDICINE

Article

Author: Tan, Ming-Hong ; Liu, Ling ; Wei, Ping ; Zhou, Liang ; Xiao, Wei-Yin ; Yi, Dong ; Jiang, Xue-Shu ; Ning, Ning

The objective of this study was to observe the antihypertensive effect of losartan and levamlodipine besylate on insulin resistance in patients with essential hypertension (EH) combined with isolated impaired fasting glucose (i-IFG). Patients (n=244) were randomly assigned to losartan potassium tablets (50-100 mg per day) or levamlodipine besylate tablets (2.5-5.0 mg per day) for intensive antihypertensive treatment with no lifestyle interventions for 3 years. The changes in fasting plasma glucose, fasting insulin (FINS) and insulin sensitivity index (ISI) from before to after treatment were observed. Blood pressure (BP) in each group was significantly reduced by treatment (P<0.05). After 12 months of treatment, the FINS level in the losartan potassium group was significantly decreased and ISI was significantly increased compared with before treatment (P<0.05) and compared with the levamlodipine besylate group (P<0.05). After 24 and 36 months of treatment, FINS was significantly decreased and ISI was significantly improved in both groups compared with baseline (P<0.05), and there was no difference between the groups (P>0.05). The incidence of new-onset diabetes mellitus was not significantly different between two groups. The antihypertensive effect of losartan and levamlodipine besylate could amoliorate insulin resistance in patients with EH combined with i-IFG. The improvement of insulin resistance by losartan potassium at 12 months might be better than that by levamlodipine besylate; however, after 24 and 36 months of follow-up, both agents significantly alleviated insulin resistance. These results suggest that the effects of these two drugs on insulin resistance are not significantly different.

100 Deals associated with Levamlodipine Besylate

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Angina Pectoris	KR	AHN-GOOK PHARMACEUTICAL Co., Ltd.	01 Jan 2006
Hypertension	KR	AHN-GOOK PHARMACEUTICAL Co., Ltd.	01 Jan 2006

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Angina Pectoris	Phase 1	CN	Nanchang Weiyang Biochemical Pharmaceutical Co., Ltd.	21 Jun 2022
Hypertension	Phase 1	CN	Nanchang Weiyang Biochemical Pharmaceutical Co., Ltd.	21 Jun 2022

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