[Translation] A randomized, double-blind, positive-drug parallel-controlled, multicenter clinical trial of clibacter tablets in the treatment of primary hyperlipidemia

以非诺贝特片为对照，评价克利贝特片治疗原发性高脂血症的有效性和安全性

[Translation]

To evaluate the efficacy and safety of clinofibrate tablets in the treatment of primary hyperlipidemia using fenofibrate tablets as a control

Start Date-

Sponsor / Collaborator

Tianjin Hankang Pharmaceutical Biotechnology Co. Ltd.

100 Clinical Results associated with Clinofibrate

100 Translational Medicine associated with Clinofibrate

100 Patents (Medical) associated with Clinofibrate

Literatures (Medical) associated with Clinofibrate

01 Jan 2018·Journal of Veterinary Medical ScienceQ4 · AGRICULTURAL & FORESTRY SCIENCE

Clinofibrate improved canine lipid metabolism in some but not all breeds

Q4 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: YASUDA, Hidemi ; ARAI, Nobuaki ; SATO, Yohtaro ; MIZOGUCHI, Yasushi

The objectives of this study were to assess if Clinofibrate (CF) treatment improved lipid metabolism in dogs, and to clarify whether its efficacy is influenced by canine characteristics. We collected medical records of 306 dogs and performed epidemiological analyses. Lipid values of all lipoproteins were significantly decreased by CF medication, especially VLDL triglyceride (TG) concentration (mean reduction rate=54.82%). However, 17.65% of dogs showed drug refractoriness in relation to TG level, and Toy Poodles had a lower CF response than other breeds (OR=5.36, 95% CI=2.07-13.90). Therefore, our study suggests that genetic factors may have an effect on CF response, so genetic studies on lipid metabolism-related genes might be conducted to identify variations in CF efficacy.

01 Apr 2015·Die Pharmazie

Development of a LC-MS/MS method for the estimation of clinofibrate in human urine.

Article

Author: Li, Fan ; Ai-Dong, Wen ; Wei, Song ; Yang, Jing ; Xueqing, Li ; Ge, Jie ; Ding, Likun ; Lu, Chentao ; Li, Jian-Kang

A highly sensitive and rapid liquid chromatography-tandem mass spectrometry method was developed for the determination of clinofibrate in human urine. The analyte and IS were extracted through a simple protein precipitation by the mixture of acetonitrile and 1 mol/L hydrochloric acid (95:5, v/v) and separated on an Inspire C18 (150 mm x 4.6 mm I.D., 5 μm particle size) column using isocratic elution with methanol and water containing 0.1% formic acid and 10 mM ammonium acetate (90:10, v/v). Mass spectrometric detection was performed in electrospray positive ionization MRM mode. The mass transition was m/z 486.3-->175.0 for clinofibrate and m/z 361.1-->233.1 for IS, respectively. The flow rate was 0.6 mL/min and the column oven temperature was set at 35 °C. The total run time was 6.5 min. Good linear relationships were obtained for all analytes over the concentrations ranging of 0.1002-10.02 μg/mL (r2 = 0.9991) and the limit of quantification was 0.1002 μg/mL. The extraction recovery was larger than 87.4% and intra- and inter-batch precision and accuracy with RSD were all less than 6.5%. The total amount of unchanged clinofibrate excreted in urine was less than 0.34%. This method was successfully applied to the pharmacokinetic study of clinofibrate in human urine.

01 Aug 2013·Int. Journal of Clinical Pharmacology and TherapeuticsQ4 · MEDICINE

Effect of food on the single-dose pharmacokinetics and tolerability of clinofibrate tablets in Chinese healthy volunteers

Q4 · MEDICINE

Article

Author: Wang, Lei ; Li, Jian-kang ; Ding, Li-kun ; Wen, Ai-dong ; Song, Ying ; Chen, Min-chun ; Yang, Jing ; Li, Xue-qin ; Jia, Yan-yan ; Song, Wei

The aim of this study is to investigate a food effect on the single-dose pharmacokinetics and tolerability of clinofibrate tablets in 12 Chinese healthy volunteers. The authors evaluated the effect of being under a fasting or fed state at the time of drug intake on the single-dose of clinofibrate 400 mg tablets in a randomized, balanced, single-dose, two-treatment (fed and fasting), two-period, two-sequence study design with a 7-day washout period. The end points were the maximum plasma drug concentration (Cmax) and areas under the plasma-concentration curve (AUC) for 72 hours exposure (AUC0-72) and total exposure (AUC0-∞). All participants completed the whole study without side effects being observed. The Cmax mean of clinofibrate glucuronides and parent clinofibrate were 21.91, 17.85 μ/ml for the fasting state and 13.14, 11.25 μ/ml for the fed state, respectively. The AUC0-72 and AUC0-∞ of clinofibrate glucuronides and parent clinofibrate were 381.60, 307.07 μ/ ml and 404.55, 342.24 μ/ml for the fasting state and 379.02, 321.14 μ/ml and 432.24, 351.80 μ/ml for the fed state. The authors showed that food intake was associated with a significant decrease in Cmax, but no significant change in AUC values.

100 Deals associated with Clinofibrate

External Link

KEGG	Wiki	ATC	Drug Bank
D01300	Clinofibrate	C10AB	DB09006

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hyperlipidemias	JP	Sumitomo Pharma Co., Ltd.	01 Jan 1981

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Primary Hyperlipidemia	Phase 2	CN	Tianjin Hankang Pharmaceutical Biotechnology Co. Ltd.	03 Mar 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis