Pharmacokinetics and Bioequivalence Evaluation of Two Acipimox Tablets: A Single-Dose, Randomized-Sequence, Two-Way Crossover Study in Healthy Chinese Male Volunteers

Huang, Jinkun; Chen, R.; Wei, Chen; Li, R.; Yuan, Gang; Liu, X.; Wang, B.; Guo, Ruru

doi:10.1055/s-0032-1333228

Cited by 3 publications

(2 citation statements)

References 2 publications

(2 reference statements)

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“…This method is commonly used to compare pharmacokinetic characteristics of two drugs in bioequivalence studies. The number of patients enrolled in the study was comparable to other previous bioequivalence studies . Secondly, the difference in anaesthetic techniques could have had an influence on the amount of ipratropium bromide delivered to patients.…”

Section: Discussionsupporting

confidence: 52%

Efficiency of a New Mesh‐Type Nebulizer (NE‐SM1 NEPLUS) for Intrapulmonary Delivery of Ipratropium Bromide in Surgical Patients

Lee

Kwon²,

Park

et al. 2015

Basic Clin Pharma Tox

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This study was aimed to evaluate the efficiency of a new mesh-type nebulizer for the intrapulmonary delivery of ipratropium bromide in surgical patients under mechanical ventilation. A total of 20 patients were randomly allocated to receive 0.5 mg ipratropium bromide using either a control (Pariboy SX, Pari, Co., Starnberg, Germany, n = 10) or test (NE-SM1 NEPLUS, KTMED INC., Seoul, Korea, n = 10) nebulizer during general anaesthesia. Ipratropium bromide was nebulized continuously for 20 min. in each group. Plasma concentrations of ipratropium bromide were obtained from blood samples at preset intervals. Non-compartmental analysis of ipratropium bromide was performed to compare the efficiency of pulmonary drug delivery in both nebulizers. Population pharmacokinetic analysis of ipratropium bromide was performed. Additionally, the noise level during the nebulizer operation and the aerosol particle size for each device were measured. The dose-normalized AUC last was 0.10 min/L for both nebulizers. The pharmacokinetics of nebulized ipratropium bromide can be described best by a one-compartment model with first-order absorption. The apparent volume of distribution and metabolic clearance were 1340 L and 6.78 L/min, respectively. Type of nebulizer was a significant covariate for absorption rate constant. The equivalent sound level and median aerosol particle diameter were 35.0 dB and 4.52 lm for the test nebulizer, and 60.2 dB and 3.85 lm for the control nebulizer, respectively. From the standpoint of the dose-normalized AUC last , a new vibrating mesh-type nebulizer shows similar performance in the intrapulmonary delivery of ipratropium bromide to that of a jet-type nebulizer in surgical patients.Pulmonary drug delivery is an effective route for bronchodilator administration to manage obstructive lung diseases, including asthma and chronic obstructive pulmonary disease. Nebulizers have been used to deliver bronchodilators to the lung in various clinical situations [1]. Nebulizers can be classified into two major types according to their operating principle, jet-and ultrasonic-type nebulizers [2]. For aerosol generation, jet nebulizers function via the Bernoulli principle and use high-speed velocity compressed gas, whereas ultrasonic nebulizers use a piezoelectric crystal that vibrates at a high frequency [2]. A class of advanced ultrasonic nebulizers that used ultrasonic vibrating mesh technology were launched around 2005. In these nebulizers, a mesh with 1000-7000 laser-drilled holes vibrates at the top of the liquid reservoir, and this technology is more effective than those with a vibrating piezoelectric element at the bottom of the liquid reservoir [3]. It is known that the type of nebulizer is an important factor for determining the efficiency of pulmonary drug delivery during mechanical ventilation [4]. Recently, a vibrating meshtype nebulizer (NE-SM1 NEPLUS, KTMED INC., Seoul, Korea) was commercialized and approved for the Korean market by the Korean Ministry of Food & Drug Safety. To the best of our...

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Section: Discussionsupporting

confidence: 52%

Efficiency of a New Mesh‐Type Nebulizer (NE‐SM1 NEPLUS) for Intrapulmonary Delivery of Ipratropium Bromide in Surgical Patients

Lee

Kwon²,

Park

et al. 2015

Basic Clin Pharma Tox

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“…Thus, we hypothesize that acipimox might be able to reduce the levels of serum lipids and inflammatory reactions to play a role in stabilizing vulnerable plaques and reducing CAS. However, the clinical application of it was limited, as it has only been used in clinic or clinical trials in Denmark, 12 USA, 10 China, 13 etc. Therefore, we intend to promote the clinical application by analysing the clinical effects and safety of acipimox in patients with vulnerable CAS.…”

Section: Introductionmentioning

confidence: 99%

Investigation of the clinical effects of acipimox in patients with vulnerable carotid atherosclerosis

Huang

Liu

et al. 2022

Vascular

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Objective To investigate the clinical effects of acipimox in patients with vulnerable carotid atherosclerosis. Methods 80 patients with vulnerable carotid atherosclerosis who were admitted to the Department of Cardiology in Wuxi Second People’s Hospital between February 2020 and October 2021 were enrolled in this study. All of these patients were randomly divided into an observation group ( n = 40), who were given acipimox and conventional treatment, and a control group ( n = 40), who were given conventional treatment. The levels of blood lipids and adiponectin (APN), the carotid intima-media thickness (IMT), the area, thickness and number of CAS, peak systolic velocities (PSV) and end-diastolic blood velocity (EDV) of common carotid artery (CCA), and the level of inflammatory markers were measured and compared between the two groups pretherapy and posttreatment. Then, the adverse events were collected and compared between the two groups posttreatment. Results The demographics and basic clinical characteristics were not significantly different between the two groups. At posttreatment, the levels of TC, LDL-C, ANP, IL-6, TNF-α and hs-CRP in the observation group were significantly lower than those in the control group at posttreatment. Moreover, the IMT and the area and thickness of CAS in the observation group were significantly lower than those in the control group. After treatment, PSV was lower and EDV was higher in two groups than before treatment; after treatment, compared with control group, PSV in observation group was lower, while EDV was higher. Most importantly, the rate of adverse events was similar in the two groups. Conclusions Acipimox reduced the blood lipid levels in patients with vulnerable carotid atherosclerosis. It also stabilized vulnerable plaques and reduced CAS.

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Good Clinical Practice

2014

Handbook of Bioequivalence Testing

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Pharmacokinetics and Bioequivalence Evaluation of Two Acipimox Tablets: A Single-Dose, Randomized-Sequence, Two-Way Crossover Study in Healthy Chinese Male Volunteers

Abstract: In this small study, a single 250-mg oral dose of an acipimox tablet (test formulation) is bioequivalent to the established reference formulation.

Cited by 3 publications

References 2 publications

Efficiency of a New Mesh‐Type Nebulizer (NE‐SM1 NEPLUS) for Intrapulmonary Delivery of Ipratropium Bromide in Surgical Patients

Efficiency of a New Mesh‐Type Nebulizer (NE‐SM1 NEPLUS) for Intrapulmonary Delivery of Ipratropium Bromide in Surgical Patients

Investigation of the clinical effects of acipimox in patients with vulnerable carotid atherosclerosis

Good Clinical Practice

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