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Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin. Effect of body weight, gender, and race on systemic exposures of each drug.
J Clin Pharmacol. 2007 Jan; 47(1):37-47.JC

Abstract

Bioavailability of pioglitazone and metformin, in 2 dose strengths, given either as a fixed-dose combination tablet or as coadministration of commercial tablets (coad), was studied in young healthy subjects in 2 separate studies. In study I (n = 63), single oral doses of 15-mg pioglitazone/500-mg metformin fixed-dose combination tablets or equivalent doses of commercial tablets were administered, in a fasting state, in an open-label, randomized, crossover study with a 7-day washout period between treatments. Study II (n = 61) was similar in design to study I, except the 15/850-mg fixed-dose combination tablet and coad treatments were evaluated. Least squares mean (fixed-dose combination/coad) ratios and 90% confidence intervals of the ratios for the 15/500-mg dose strength for the maximum observed serum concentration (Cmax) and area under the serum concentration-time curve from time 0 to infinity (AUC(infinity)) were 0.95 (0.86-1.05) and 1.02 (0.98-1.08), respectively, for pioglitazone and 0.99 (0.95-1.03) and 1.03 (0.98-1.08), respectively, for metformin. Bioequivalency for pioglitazone and metformin between fixed-dose combination tablets and coad treatments was met for both strengths of fixed-dose combination tablets. In a post hoc meta-analysis of combined data from the 2 studies (n = 124), there was considerable overlapping in AUC(infinity) values between gender and race (Caucasians, Blacks, and Hispanics), making neither gender- nor racial-based dosing of pioglitazone or metformin necessary.

Authors+Show Affiliations

Takeda Global Research & Development Center, Inc, 475 Half Day Road, Lincolnshire, IL 60069, USA. akarim@tgrd.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17192500

Citation

Karim, Aziz, et al. "Oral Antidiabetic Drugs: Bioavailability Assessment of Fixed-dose Combination Tablets of Pioglitazone and Metformin. Effect of Body Weight, Gender, and Race On Systemic Exposures of Each Drug." Journal of Clinical Pharmacology, vol. 47, no. 1, 2007, pp. 37-47.
Karim A, Slater M, Bradford D, et al. Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin. Effect of body weight, gender, and race on systemic exposures of each drug. J Clin Pharmacol. 2007;47(1):37-47.
Karim, A., Slater, M., Bradford, D., Schwartz, L., Zhao, Z., Cao, C., & Laurent, A. (2007). Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin. Effect of body weight, gender, and race on systemic exposures of each drug. Journal of Clinical Pharmacology, 47(1), 37-47.
Karim A, et al. Oral Antidiabetic Drugs: Bioavailability Assessment of Fixed-dose Combination Tablets of Pioglitazone and Metformin. Effect of Body Weight, Gender, and Race On Systemic Exposures of Each Drug. J Clin Pharmacol. 2007;47(1):37-47. PubMed PMID: 17192500.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin. Effect of body weight, gender, and race on systemic exposures of each drug. AU - Karim,Aziz, AU - Slater,Margaret, AU - Bradford,Dawn, AU - Schwartz,Lisa, AU - Zhao,Zhen, AU - Cao,Charlie, AU - Laurent,Aziz, PY - 2006/12/29/pubmed PY - 2007/3/3/medline PY - 2006/12/29/entrez SP - 37 EP - 47 JF - Journal of clinical pharmacology JO - J Clin Pharmacol VL - 47 IS - 1 N2 - Bioavailability of pioglitazone and metformin, in 2 dose strengths, given either as a fixed-dose combination tablet or as coadministration of commercial tablets (coad), was studied in young healthy subjects in 2 separate studies. In study I (n = 63), single oral doses of 15-mg pioglitazone/500-mg metformin fixed-dose combination tablets or equivalent doses of commercial tablets were administered, in a fasting state, in an open-label, randomized, crossover study with a 7-day washout period between treatments. Study II (n = 61) was similar in design to study I, except the 15/850-mg fixed-dose combination tablet and coad treatments were evaluated. Least squares mean (fixed-dose combination/coad) ratios and 90% confidence intervals of the ratios for the 15/500-mg dose strength for the maximum observed serum concentration (Cmax) and area under the serum concentration-time curve from time 0 to infinity (AUC(infinity)) were 0.95 (0.86-1.05) and 1.02 (0.98-1.08), respectively, for pioglitazone and 0.99 (0.95-1.03) and 1.03 (0.98-1.08), respectively, for metformin. Bioequivalency for pioglitazone and metformin between fixed-dose combination tablets and coad treatments was met for both strengths of fixed-dose combination tablets. In a post hoc meta-analysis of combined data from the 2 studies (n = 124), there was considerable overlapping in AUC(infinity) values between gender and race (Caucasians, Blacks, and Hispanics), making neither gender- nor racial-based dosing of pioglitazone or metformin necessary. SN - 0091-2700 UR - https://www.unboundmedicine.com/medline/citation/17192500/Oral_antidiabetic_drugs:_bioavailability_assessment_of_fixed_dose_combination_tablets_of_pioglitazone_and_metformin__Effect_of_body_weight_gender_and_race_on_systemic_exposures_of_each_drug_ L2 - https://doi.org/10.1177/0091270006293755 DB - PRIME DP - Unbound Medicine ER -