Delving into the Latest Updates on Levamlodipine/Telmisartan with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

S-amlodipine/telmisartan, Telminuvo Tab, Telmisartan/S-amlodipine

+ [6]

Target

AT1R x L-type calcium channel

Action

antagonists, blockers

Mechanism

AT1R antagonists(Angiotensin II Receptor Type 1 antagonists), L-type calcium channel blockers(Voltage-gated L-type calcium channel blockers)

Therapeutic Areas

Cardiovascular DiseasesEndocrinology and Metabolic Disease

Active Indication

HypertensionEssential HypertensionDyslipidemias

Inactive Indication

Chronic Kidney DiseasesHyperlipidemias

Originator Organization

Chong Kun Dang Pharmaceutical Corp.

Active Organization

Chong Kun Dang Pharmaceutical Corp.

Jiangxi Shimei Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

South Korea (31 Jan 2013),

Hypertension

Regulation-

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Structure/Sequence

Molecular FormulaC33H30N4O2

InChIKeyRMMXLENWKUUMAY-UHFFFAOYSA-N

CAS Registry144701-48-4

View All Structures (2)

主要研究目的：研究空腹/餐后状态下口服受试制剂替米沙坦左氨氯地平片（江西施美药业股份有限公司生产）与参比制剂替米沙坦片（商品名：美卡素，Boehringer Ingelheim Hellas Single Member S.A.生产）和苯磺酸氨氯地平片（商品名：Norvasc，辉瑞制药有限公司生产）在中国健康成年受试者体内的药代动力学特征，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂替米沙坦左氨氯地平片和参比制剂美卡素和Norvasc在中国健康成年受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Telmisartan Levoamlodipine Tablets (produced by Jiangxi Shimei Pharmaceutical Co., Ltd.) and the reference preparations Telmisartan Tablets (trade name: Micardis, produced by Boehringer Ingelheim Hellas Single Member S.A.) and Amlodipine Besylate Tablets (trade name: Norvasc, produced by Pfizer Pharmaceuticals Co., Ltd.) in healthy Chinese adult subjects in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary purpose of the study is to evaluate the safety of the test preparation Telmisartan Levoamlodipine Tablets and the reference preparations Micardis and Norvasc in healthy Chinese adult subjects.

Start Date05 Sep 2024

Sponsor / Collaborator

Jiangxi Shimei Pharmaceutical Co., Ltd.

CTR20242170

/ RecruitingPhase 3

替米沙坦左氨氯地平片（80mg/2.5mg）用于苯磺酸氨氯地平片（5mg）单药治疗4 周血压不能有效控制的原发性轻、中度高血压患者的有效性和安全性的随机、双盲双模拟、阳性药平行对照、多中心III 期临床研究

[Translation] A randomized, double-blind, double-dummy, active drug parallel-controlled, multicenter Phase III clinical study on the efficacy and safety of telmisartan levobamlodipine tablets (80mg/2.5mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled by amlodipine besylate tablets (5mg) alone for 4 weeks

评价替米沙坦左氨氯地平片（80mg/2.5mg）用于苯磺酸氨氯地平片（5mg）单药治疗4 周血压不能有效控制的原发性轻、中度高血压患者的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of telmisartan levoamlodipine tablets (80mg/2.5mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled by amlodipine besylate tablets (5mg) alone for 4 weeks.

Start Date23 Jul 2024

Sponsor / Collaborator

Jiangxi Shimei Pharmaceutical Co., Ltd.

NCT06112678

/ CompletedPhase 1

A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-348(6) Compared With Co-administration of CKD-828, D097, and D337 in Healthy Adult Volunteers

A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348(6).

Start Date04 Jan 2024

Sponsor / Collaborator

Chong Kun Dang Pharmaceutical Corp.

100 Clinical Results associated with Levamlodipine/Telmisartan

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100 Translational Medicine associated with Levamlodipine/Telmisartan

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100 Patents (Medical) associated with Levamlodipine/Telmisartan

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2

Literatures (Medical) associated with Levamlodipine/Telmisartan

Drug Design, Development and TherapyQ3 · MEDICINE

Pharmacokinetic and bioequivalence study of a telmisartan/S-amlodipine fixed-dose combination (CKD-828) formulation and coadministered telmisartan and S-amlodipine in healthy subjects

Q3 · MEDICINE

ArticleOA

Author: Kang, Woo Youl ; Ohk, Boram ; La, Sookie ; Lee, Hae Won ; Cho, Seungil ; Yoon, Young-Ran ; Yang, Dong Heon ; Kim, Bo Kyung ; Seong, Sook Jin ; Kim, Hyun-Ju ; Gwon, Mi-Ri

PURPOSEA new fixed-dose combination (FDC) formulation of telmisartan 80 mg and S-amlodipine 5 mg (CKD-828) has been developed to increase convenience (as only one tablet is required per day) and improve treatment compliance.METHODSThe pharmacokinetic characteristics and tolerability of an FDC of telmisartan and S-amlodipine were compared to those after coadministration of the individual agents in this randomized, open-label, single-dose, two-way, four-period, crossover study. To analyze the telmisartan and S-amlodipine plasma concentrations using a validated liquid chromatography-tandem mass spectrometry method, serial blood samples were collected up to 48 hours post-dose for telmisartan and 144 hours post-dose for S-amlodipine, in each period.RESULTSForty-eight healthy subjects were enrolled, and 43 completed the study. The mean peak plasma concentration (C_max) and the area under the plasma concentration-time curve from time 0 to the last measurement (AUC_0-t) values of telmisartan were 522.29 ng/mL and 2,475.16 ng·h/mL for the FDC, and 540.45 ng/mL and 2,559.57 ng·h/mL for the individual agents concomitantly administered, respectively. The mean C_max and AUC_0-t values of S-amlodipine were 2.71 ng/mL and 130.69 ng·h/mL for the FDC, and 2.74 ng/mL and 129.81 ng·h/mL for the individual agents concomitantly administered, respectively. The geometric mean ratio (GMR) and 90% confidence interval (CI) for the telmisartan C_max and AUC_0-t (FDC of telmisartan and S-amlodipine/concomitant administration) were 0.8509 (0.7353-0.9846) and 0.9431 (0.8698-1.0226), respectively. The GMR and 90% CI for the S-amlodipine C_max and AUC_0-t (FDC/concomitant administration) were 0.9829 (0.9143-1.0567) and 0.9632 (0.8798-1.0546), respectively. As the intrasubject variability of the C_max for telmisartan administered individually was 42.94%, all 90% CIs of the GMRs fell within the predetermined acceptance range. Both treatments were well tolerated in this study.CONCLUSIONCKD-828 FDC tablets were shown to be bioequivalent to coadministration of the individual agents with the respective strength, in healthy subjects under fasting conditions. There was no significant difference in safety profile between the two treatments.

Drug Design, Development and TherapyQ3 · MEDICINE

Efficacy and safety of two fixed-dose combinations of S-amlodipine and telmisartan (CKD-828) versus S-amlodipine monotherapy in patients with hypertension inadequately controlled using S-amlodipine monotherapy: an 8-week, multicenter, randomized, double-blind, Phase III clinical study

Q3 · MEDICINE

ArticleOA

Author: Hwang, Kyung-Kuk ; Cha, Tae-Joon ; Youn, Ho-Joong ; Yoon, Jung Han ; Yoon, Namsik ; Kim, Sang-Hyun ; Lee, Nae-Hee ; Jeon, Hui-Kyung ; Hong, Taek-Jong ; Ihm, Sang-Hyun ; Jo, Sang-Ho

PURPOSETo evaluate the blood pressure (BP) lowering efficacy and safety of CKD-828, a fixed-dose combination of S-amlodipine (the more active isomer of amlodipine besylate, which is calcium channel blocker) and telmisartan (long acting angiotensin receptor blocker), in patients with hypertension inadequately controlled with S-amlodipine monotherapy.PATIENTS AND METHODSEligible patients (N=187) who failed to respond after 4-week S-amlodipine 2.5 mg monotherapy (sitting diastolic blood pressure [sitDBP] ≥90 mmHg) to receive CKD-828 2.5/40 mg (n=63), CKD-828 2.5/80 mg (n=63), or S-amlodipine 2.5 mg (n=61) for 8 weeks. The primary efficacy endpoint, mean sitDBP change from baseline to Week 8, was compared between the combination (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) and S-amlodipine monotherapy groups. The safety was assessed based on adverse events, vital signs, and physical examination findings.RESULTSAfter the 8-week treatment, changes in sitDBP/systolic BP (SBP) were -9.67±6.50/-12.89±11.78, -10.72±6.19/-13.79±9.41, and -4.93±7.26/-4.55±11.27 mmHg in the CKD-828 2.5/40 mg (P<0.0001/P<0.0001), CKD-828 2.5/80 mg (P<0.0001/P<0.0001), and S-amlodipine 2.5 mg (P<0.0001/P=0.0027) groups, respectively, which were all significant BP reductions. At Week 8, the CKD-828 2.5/40 mg (sitDBP/SBP: P=0.0002/P<0.0001) and CKD-828 2.5/80 mg (sitDBP/SBP: P=0.0001/P<0.0001) showed superior BP-lowering effects to S-amlodipine 2.5 mg (P<0.001). At Week 4, all groups showed significant antihypertensive effects but both CKD-828 combinations (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) exhibited superior BP-lowering effects to that of S-amlodipine 2.5 mg (sitDBP/SBP: P=0.0028/P=0.0001 and P<0.0001/P=0.0012, respectively). The adverse event incidence was significantly lower in the CKD-828 2.5/40 mg (9.52%, P=0.0086) than in the S-amlodipine 2.5 mg group (27.87%) and increasing the telmisartan dose induced no unexpected adverse events, suggesting the safety of CKD-828.CONCLUSIONCKD-828 is an effective and safe option for patients with inadequate responses to S-amlodipine monotherapy.

100 Deals associated with Levamlodipine/Telmisartan

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	South Korea	Chong Kun Dang Pharmaceutical Corp.	31 Jan 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 3	China	Jiangxi Shimei Pharmaceutical Co., Ltd.	23 Jul 2024
Hypertension	Phase 1	United States	Chong Kun Dang Pharmaceutical Corp.	01 Nov 2010
Dyslipidemias	Preclinical	South Korea	Chong Kun Dang Pharmaceutical Corp.	23 Oct 2019
Hyperlipidemias	Preclinical	United States	Chong Kun Dang Pharmaceutical Corp.	01 Apr 2013
Chronic Kidney Diseases	Preclinical	South Korea	Chong Kun Dang Pharmaceutical Corp.	01 Jul 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESH2024	Not Applicable	Hypertension	-	Telmisartan/S-Amlodipine single-pill combination	(kzjbnhyikj) = onygcdcecn avxmkluoke (lspcxwrbgv ) View more	Positive	01 May 2024