Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Bioequivalence evaluating method for medicines for reducing blood sugar by using pharmacodynamics as index

A pharmacodynamic and hypoglycemic technology, applied in the field of efficacy evaluation, can solve the problems of bioequivalence of pharmacokinetic parameters evaluation, and achieve the effect of improving evaluation consistency

Inactive Publication Date: 2019-03-29
金日制药(中国)有限公司
View PDF1 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, such drugs only work in the human intestinal tract, and are not or rarely absorbed through the intestinal tract and enter the blood drug circulation, so it is impossible to evaluate their bioequivalence with pharmacokinetic parameters. Therefore, it is recommended to use pharmacodynamic parameters Blood glucose concentration is used as the measurement target of healthy subjects, and bioequivalence evaluation is carried out

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Bioequivalence evaluating method for medicines for reducing blood sugar by using pharmacodynamics as index
  • Bioequivalence evaluating method for medicines for reducing blood sugar by using pharmacodynamics as index
  • Bioequivalence evaluating method for medicines for reducing blood sugar by using pharmacodynamics as index

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Example 1 Acarbose Tablets Bioequivalence Test Protocol.

[0013] 1. Subject requirements: A total of 54 healthy adult males and females, whose weight and height are within the standard range. After physical examination and laboratory examination, it was confirmed that they are in good health, with normal liver and kidney functions, and normal cardiovascular system functions. Written informed consent should be obtained before the experiment.

[0014] 2. Test groups.

[0015] The subjects were randomly divided into three groups, with 18 people in each group. According to the self-control three-cycle three-crossover drug design, each group was crossed with the reference drug, the comparison drug and the untested drug test, and the drug withdrawal period was 5 days. day.

[0016]

[0017] Subjects in any period of the three cycles, the administration plan is, the subjects fasted for one night, in the morning on an empty stomach, drink water to deliver reference or tes...

Embodiment 2

[0020] Example 2 Bioequivalence test and dosage regimen of voglibose tablets.

[0021] 1. Requirements for subjects: 60 healthy adult males and females, whose weight and height are within the standard range. After physical examination and laboratory examination, it is confirmed that they are in good health, with normal liver and kidney functions, and normal cardiovascular system functions. Written informed consent should be obtained before the experiment.

[0022] 2. Test groups.

[0023] The subjects were randomly divided into three groups, 20 people in each group, according to the self-control three-cycle three-cross-administration design, each group was crossed with the reference drug, the comparison drug and the untested drug test, and the drug withdrawal period was 5 days. day.

[0024]

[0025] 3. Dosing regimen.

[0026]Subjects in any period of the three cycles, the administration plan is, the subjects fasted for one night, in the morning on an empty stomach, dri...

Embodiment 3

[0029] Example 3 Miglitol Tablets Bioequivalence Test and Dosing Scheme.

[0030] 1. Subject requirements: 48 healthy adult males and females, whose weight and height are within the standard range. After physical examination and laboratory examination, it is confirmed that they are in good health, with normal liver and kidney functions, and normal cardiovascular system functions. Written informed consent should be obtained before the experiment.

[0031] 2. Test groups.

[0032] The subjects were randomly divided into three groups, 16 people in each group, according to the self-control three-cycle three-cross-administration design, each group was cross-tested with reference drug, comparison drug and blank drug, and the drug withdrawal period was 5 days .

[0033]

[0034] 3. Dosing regimen.

[0035] Subjects in any period of three cycles, the administration plan is, the subjects fasted for one night, in the morning on an empty stomach, drink water to deliver reference or...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention provides a bioequivalence evaluating method for medicines for reducing blood sugar by using pharmacodynamics as an index, and relates to a three-cycle three-cross bioequivalence evaluating method by using pharmacodynamics parameters of blood sugar concentration as an evaluating index, wherein the medicines are mainly alpha-glycosidase inhibitor type medicines. Examines are divided into three groups randomly, and are respectively subjected to medicine test of reference medicines, contrast medicines and vacancy medicines at the three-cycle experiment stage, and then are subjected to glucose load experiment, and besides, blood samples within 4 hours are collected, and concentration determination results of glucose in serum are recorded as the blood sugar concentration. Evaluating parameters include the largest blood sugar concentration difference (delta Cmax) of the examinees under the condition of being subjected to medicine test of the reference medicines or the contrast medicines and the vacancy medicines; and the 2-4-hoursblood sugar concentration-time area under curve difference (delta AUC0-n) of the examinee under the condition of being subjected to medicine test of reference medicines or contrast medicines or vacancy medicine. The judgment standard lies in that the equivalence standard lies in that the 90% confidence interval of the group geometric mean valueratio of the delta Cmax to the delta AUC0-n in the evaluating parameters of a test preparation and the contrast medicines needs to fall in the range of 80%-125%.

Description

technical field [0001] The invention provides a bioequivalence evaluation method for hypoglycemic drugs with pharmacodynamics as an index, which belongs to the field of medical technology, and specifically relates to a three-cycle three-cross bioequivalence evaluation method with blood glucose concentration as a pharmacodynamic index. The method of the present invention The method can be used in clinical medicine and clinical evaluation of drug efficacy. Background technique [0002] Bioequivalence evaluation compares the test drug with the reference drug through biological indicators. However, the absorption and distribution of the drug in the body is too low, and the concentration of the drug and its metabolites in plasma and / or urine cannot be determined by existing detection methods In some cases, pharmacodynamic indicators should be considered for evaluation. [0003] Acarbose, voglibose, miglitol and other α-glucosidase inhibitor hypoglycemic drugs act on α-glucosida...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): A61K49/00
CPCA61K49/0004
Inventor 周丽娟吴晶李新南廖雪倩
Owner 金日制药(中国)有限公司
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com