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Bioequivalence and pharmacokinetic comparison of 3 metformin extended/sustained release tablets in healthy Indian male volunteers.
Arzneimittelforschung. 2012 Jan; 62(1):22-6.A

Abstract

This study was undertaken to compare the bioavailability and pharmacokinetic properties of 3 marketed product of metformin (CAS 1115-70-4) extended/sustained release formulation in Indian male volunteers. Study was designed as an open-label, randomized, 3-treatment, single-dose, crossover, bioavailability study comparing 3 marketed brands of 500 mg metformin extended/sustained release tablets in 18 healthy human male volunteers under fed condition. A single oral dose of 500 mg metformin sustained release products, test A (Glycomet SR), test B (Bigomet SR) and extended release reference product was administered as per computer generated randomization schedule during 3 period of the study having 7 days of washout period. A liquid Chromatography mass spectroscopy method for the determination of metformin in human plasma was developed and validated using metformin-D6 as an internal standard. A noncompartment pharmacokinetic method was employed to determine the pharmacokinetic parameters (Cmax, Tmax, AUC0-t, AUC0-∞ and t½) of metformin using WinNonlin-Node 4.0 software. Cmax, AUC0-t and AUC0-∞ were used to test for bioequivalence after log transformation of plasma data. The predetermined regulatory range of 90% CI for bioequivalence was 0.80 to 1.25. The 90% confidence intervals for log transformed data for Cmax, AUC0-t and AUC0-∞ for test A vs. reference were 82.11-98.91, 86.29-102.17 and 86.34-102.59 respectively whereas for test B vs. reference were 104.39-125.76, 94.78-112.22 and 92.85-110.33 respectively. The results of this study suggest that the test A was bioequivalent to reference product, whereas test B was not as per regulatory defined criteria.

Authors+Show Affiliations

Faculty of Pharmaceutical Medicine, Jamia Hamdard, New Delhi, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22331759

Citation

Batolar, L S., et al. "Bioequivalence and Pharmacokinetic Comparison of 3 Metformin Extended/sustained Release Tablets in Healthy Indian Male Volunteers." Arzneimittel-Forschung, vol. 62, no. 1, 2012, pp. 22-6.
Batolar LS, Iqbal M, Monif T, et al. Bioequivalence and pharmacokinetic comparison of 3 metformin extended/sustained release tablets in healthy Indian male volunteers. Arzneimittelforschung. 2012;62(1):22-6.
Batolar, L. S., Iqbal, M., Monif, T., Khuroo, A., & Sharma, P. L. (2012). Bioequivalence and pharmacokinetic comparison of 3 metformin extended/sustained release tablets in healthy Indian male volunteers. Arzneimittel-Forschung, 62(1), 22-6. https://doi.org/10.1055/s-0031-1295428
Batolar LS, et al. Bioequivalence and Pharmacokinetic Comparison of 3 Metformin Extended/sustained Release Tablets in Healthy Indian Male Volunteers. Arzneimittelforschung. 2012;62(1):22-6. PubMed PMID: 22331759.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bioequivalence and pharmacokinetic comparison of 3 metformin extended/sustained release tablets in healthy Indian male volunteers. AU - Batolar,L S, AU - Iqbal,M, AU - Monif,T, AU - Khuroo,A, AU - Sharma,P L, Y1 - 2012/01/10/ PY - 2012/2/15/entrez PY - 2012/2/15/pubmed PY - 2012/3/23/medline SP - 22 EP - 6 JF - Arzneimittel-Forschung JO - Arzneimittelforschung VL - 62 IS - 1 N2 - This study was undertaken to compare the bioavailability and pharmacokinetic properties of 3 marketed product of metformin (CAS 1115-70-4) extended/sustained release formulation in Indian male volunteers. Study was designed as an open-label, randomized, 3-treatment, single-dose, crossover, bioavailability study comparing 3 marketed brands of 500 mg metformin extended/sustained release tablets in 18 healthy human male volunteers under fed condition. A single oral dose of 500 mg metformin sustained release products, test A (Glycomet SR), test B (Bigomet SR) and extended release reference product was administered as per computer generated randomization schedule during 3 period of the study having 7 days of washout period. A liquid Chromatography mass spectroscopy method for the determination of metformin in human plasma was developed and validated using metformin-D6 as an internal standard. A noncompartment pharmacokinetic method was employed to determine the pharmacokinetic parameters (Cmax, Tmax, AUC0-t, AUC0-∞ and t½) of metformin using WinNonlin-Node 4.0 software. Cmax, AUC0-t and AUC0-∞ were used to test for bioequivalence after log transformation of plasma data. The predetermined regulatory range of 90% CI for bioequivalence was 0.80 to 1.25. The 90% confidence intervals for log transformed data for Cmax, AUC0-t and AUC0-∞ for test A vs. reference were 82.11-98.91, 86.29-102.17 and 86.34-102.59 respectively whereas for test B vs. reference were 104.39-125.76, 94.78-112.22 and 92.85-110.33 respectively. The results of this study suggest that the test A was bioequivalent to reference product, whereas test B was not as per regulatory defined criteria. SN - 0004-4172 UR - https://www.unboundmedicine.com/medline/citation/22331759/Bioequivalence_and_pharmacokinetic_comparison_of_3_metformin_extended/sustained_release_tablets_in_healthy_Indian_male_volunteers_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0031-1295428 DB - PRIME DP - Unbound Medicine ER -