Delving into the Latest Updates on Amlodipine Nicotinate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Naidipine

Target

VDCCs

Mechanism

VDCCs blockers(Voltage-gated calcium channel blockers)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Hypertension

Inactive Indication-

Originator Organization

Hanlim Pharm Co., Ltd.

Active Organization

Hanlim Pharm Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Structure

Molecular FormulaC26H30ClN3O7

InChIKeyVLDHKVLFLLOUKI-UHFFFAOYSA-N

CAS Registry616203-96-4

View All Structures (2)

To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults

Start Date01 Dec 2013

Sponsor / Collaborator

Hanlim Pharm Co., Ltd.

NCT01819779 / CompletedPhase 1

Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects

To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab

Start Date01 Mar 2013

Sponsor / Collaborator

Hanlim Pharm Co., Ltd.

NCT01652339 / CompletedPhase 1

Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects

To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male subjects
PK parameter evaluation
Safety profile evaluation

Start Date01 Jul 2012

Sponsor / Collaborator

Hanlim Pharm Co., Ltd.

100 Clinical Results associated with Amlodipine Nicotinate

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100 Translational Medicine associated with Amlodipine Nicotinate

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100 Patents (Medical) associated with Amlodipine Nicotinate

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6

Literatures (Medical) associated with Amlodipine Nicotinate

01 Jul 2017·Clinical TherapeuticsQ4 · MEDICINE

Bioequivalence Study of a New Fixed-dose Combination Tablet Containing S-Amlodipine Nicotinate and Olmesartan Medoxomil in Healthy Korean Male Subjects

Q4 · MEDICINE

Article

Author: Lee, Sun Young ; Lee, Geun Hyeog ; Hwang, Hyun Hwan ; Kang, Soo Yeon ; Jang, Choon-Gon ; Lee, Seok-Yong ; Cho, Kyung Hee ; Lee, Yun Jeong ; Kim, Hyun Gyu ; Lee, Yun Young ; Cho, Yun-Seok ; Oh, Mi Jin

PURPOSEA fixed-dose combination (FDC) pill of amlodipine (relatively old calcium channel blocker as dihydropyridine) and olmesartan (relatively new angiotensin II receptor blocker) is used for hypertension that is not adequately controlled with a single-formulation drug. Because the FDC is a one-pill formulation, and amlodipine and olmesartan have different mechanisms of action, it is expected to improve patients' medication compliance and have an increased blood pressure-lowering efficacy. The purpose of this study was to assess the safety profile and the bioequivalence of two different FDC formulations [amlodipine besylate/olmesartan medoxomil 10/40 mg (reference product) and S-amlodipine nicotinate/olmesartan medoxomil 5/40 mg (test product)].METHODSA randomized, open-label, single-dose, 2-treatment, 2-way, and 2-period crossover study, including a 3-week washout period, was performed in 32 healthy Korean male volunteers. To analyze the concentration of S-amlodipine or olmesartan, plasma samples were collected up to 144 hours after the dose for S-amlodipine and 48 hours after the dose for olmesartan. Pharmacokinetic parameters, including the C_max and the area under the curve from time 0 to the last measurable concentration (AUC_0-last) for the time versus concentration plot, were calculated. Analysis of variance for bioequivalence was conducted using C_max and AUC_0-last converted to log scale, and the mean ratios and 90% CIs were determined. Safety data included analysis of adverse events (AEs), vital signs, physical examinations, clinical laboratory test, and 12-lead ECGs.FINDINGSOf the 32 enrolled participants, 29 healthy volunteers completed the study. For both S-amlodipine and olmesartan, the main pharmacokinetic parameters were all within the acceptable range for regulatory bioequivalence. The 90% CIs for the geometric mean ratios of C_max and AUC_0-last were 0.8766 to 0.9760 and 0.8288 to 0.9224, respectively, for S-amlodipine and 0.9097 to 1.1229 and 0.8904 to 1.0407, respectively, for olmesartan. Hypotension was the most frequent AE, and it was observed in 4 volunteers with the test product and 7 volunteers with the reference product. Both the test and reference formulations were well tolerated.IMPLICATIONSThe present study demonstrates that the newly developed FDC product (test drug) and the conventional FDC product (reference drug) have comparable pharmacokinetic characteristics in healthy adult male volunteers. Both the test and reference products indicated good tolerance in this population, and no serious AEs were observed.

01 Jan 2014·Eksperimental'naia i klinicheskaia farmakologiia

[Effect of S-amlodipine nicotinate on the cerebral circulation in rats under conditions of ischemic and hemorrhagic brain injury].

Article

Author: Mirzoian, R S ; Kurdiumov, I N ; Gnezdilova, A V ; Gan'shina, T S ; Kim, G A

We have performed a comparative study of the effects of S-amlodipine nicotinate and nimodipine on the local cerebral blood flow were studied in intact rats and those with model ischemic and hemorrhagic brain injury. It is established that S-amlodipine nicotinate produces a somewhat more pronounced enhancement of cerebral blood flow in rats with ischemic and hemorrhagic brain injury than in intact animals. In addition, S-amlodipine nicotinate significantly exceed nimodipine with respect to cerebrovascular activity in rats with brain pathology of both ischemic and hemorrhagic nature.

01 Jan 2014·Eksperimental'naia i klinicheskaia farmakologiia

[Comparative study of the effect of S-amlodipine nicotinate and amlodipine benzylate on the arterial pressure of awake rats].

Article

Author: Mirzoian, R S ; Gnezdilova, A V ; Gorbunov, A A ; Gan'shina, T S ; Kim, G A

We have performed a comparative study of the effects of two calcium channel blockers, S-amlodipine nicotinate and amnlodipine benzylate, on the arterial pressure (AP) of awake rats measured in the tail artery. The results of experiments showed that both preparations produce a statistically significant long-term decrease in the AP of animals. In respect of both strength and duration of the hypotensive effect, S-amlodipine nicotinate somewhat exceeds amnlodipine benzylate.

100 Deals associated with Amlodipine Nicotinate

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