NDLI: Pharmacokinetics and relative bioavailability of metformin hydrochloride extended-release tablets in healthy volunteers

Please wait, while we are loading the content...

Pharmacokinetics and relative bioavailability of metformin hydrochloride extended-release tablets in healthy volunteers

Content Provider	Semantic Scholar
Author	Song, Nai-Ning Huang, Yu-Rong Zheng, Bao-Zhong Feng, Ping Liu, Changxiao
Copyright Year	2006
Abstract	Aim To evaluate the pharmacokinetic and relative bioavailability of metformin hydrochloride extended-release tablets made in two formulations (test drugs, T1, T2) to metformin hydrochloride extended-release tablets already for sale (reference product, R). Methods An open-label, randomized and crossover clinical trials recruited 18 healthy volunteers were carried out for single-dose (1000mg) and multiple-doses (1000mg·d × 7d) administration study. The plasma metformin concentrations were determined using HPLC method. Results Various pharmacokinetic parameters were determined from plasma metformin concentrations. After single-dose administration (T1, T2, R), there was no statistical significant difference in AUC, Cmax and tmax either among the three treatments or among formulations by ANOVA after log-transformation of the data and two one-sided t-test, and the relative bioavailabilities for test drugs to the reference drug, were 98.8%±13.0% and 96.7%±14.6% respectively. After multiple-doses administration (T2, R), no statistically significant difference was found in AUCss, Cmax and tmax between test drug and reference product evaluated by ANOVA after log-transformation of the data and two one-sided t-test. Besides, there was no statistically significant difference in Cmin, Cav and DF between test drug and reference product evaluated by paired-sample t-test. The relative bioavailability for the test drug to the reference product was 94.6%±14.0%. Conclusion The reference metformin product is bioequivalent to the test two formulations of metformin hydrochloride tablets, and it is suggested that the test drugs and reference product are of equal clinical efficacy.
File Format	PDF HTM / HTML
Alternate Webpage(s)	http://hktmc.com.cn/ChineseMedia/Magazine/Medicine/ajdmpk/AJDMPK-2006-1/asian6-1(55-62)(Song%20Nai-Ning).pdf
Language	English
Access Restriction	Open
Content Type	Text
Resource Type	Article

Central Library (ISO-9001:2015 Certified)
Indian Institute of Technology Kharagpur
Kharagpur, West Bengal, India | PIN - 721302

See location in the Map
03222 282435
Mail: support@ndl.gov.in

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in