NDLI: Pharmacokinetics of Empagliflozin and Pioglitazone After Coadministration in Healthy Volunteers.

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

Year: 2017 Volume: 39

Year: 2016 Volume: 38

Year: 2015 Volume: 37

Year: 2015 Volume: 37 Issue: 12

Year: 2015 Volume: 37 Issue: 11

Year: 2015 Volume: 37 Issue: 10

Year: 2015 Volume: 37 Issue: 9

Year: 2015 Volume: 37 Issue: 8

Year: 2015 Volume: 37 Issue: 7

Role of the Pharmacist in Medication Therapy Management Services in Patients With Osteoporosis.

Effects of Febuxostat on Oxidative Stress.

Population Pharmacokinetic and Pharmacodynamic Modeling and Effects on Platelet Counts of Different Dosages of Eltrombopag in Chinese Patients With Chronic Primary Immune Thrombocytopenia.

Efficacy of Tenofovir-based Rescue Therapy in Lamivudine-resistant Chronic Hepatitis B Patients With Failure of Lamivudine and Adefovir Combination.

Effects of Hemodialysis on Methadone Pharmacokinetics and QTc.

How Did Multiple FDA Actions Affect the Utilization and Reimbursed Costs of Thiazolidinediones in US Medicaid?

Clinical Outcomes of Daptomycin for Vancomycin-resistant Enterococcus Bacteremia.

Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate.

Impact of Switching From an Initial Tumor Necrosis Factor Inhibitor on Health Care Resource Utilization and Costs Among Patients With Rheumatoid Arthritis.

Direct Medical Costs and Utilization of Health Care Services to Treat Pneumonia in the United States: An Analysis of the 2007-2011 Medical Expenditure Panel Survey.

Sulfonylurea Prescribing Patterns After the Introduction of DPP-4 Inhibitors and GLP-1 Receptor Agonists.

Boceprevir for Chronic Genotype 1 Hepatitis C Virus in the Current Health Care Setting in Greece: A Cost-effectiveness Analysis.

Bioequivalence, Food Effect, and Steady-State Assessment of Dapagliflozin/Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects.

Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Canagliflozin in Healthy Chinese Subjects.

Providing Quality Therapeutics in Switzerland: Role of the Stakeholders and Recent Incentives for Further Improvements.

Pharmacokinetics of Empagliflozin and Pioglitazone After Coadministration in Healthy Volunteers.

Susceptibility Profile of Ceftolozane/Tazobactam and Other Parenteral Antimicrobials Against Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa From US Hospitals.

Effects of Food Intake on the Relative Bioavailability of Amifampridine Phosphate Salt in Healthy Adults.

Pharmacokinetic and Pharmacodynamic Properties and Tolerability of Single- and multiple-dose Once-daily Empagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, in Chinese Patients With Type 2 Diabetes Mellitus.

Effect of Retosiban on Cardiac Repolarization in a Randomized, Placebo- and Positive-controlled, Crossover Thorough QT/QTc Study in Healthy Men and Women.

Proof of Feasibility: What a Pilot Study Is and Is Not.

Year: 2015 Volume: 37 Issue: 6

Year: 2015 Volume: 37 Issue: 5

Year: 2015 Volume: 37 Issue: 4

Year: 2015 Volume: 37 Issue: 3

Year: 2015 Volume: 37 Issue: 2

Year: 2015 Volume: 37 Issue: 1

Year: 2014 Volume: 36

Year: 2013 Volume: 35

Year: 2012 Volume: 34

Year: 2011 Volume: 33

Year: 2010 Volume: 32

Year: 2009 Volume: 31

Year: 2008 Volume: 30

Year: 2008 Volume: 30 Spec No

Year: 2008 Volume: 30 Pt 2

Year: 2007 Volume: 29

Pharmacokinetics of Empagliflozin and Pioglitazone After Coadministration in Healthy Volunteers.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Macha, Sreeraj Mattheus, Michaela Pinnetti, Sabine Broedl, Uli C. Woerle, Hans J.
Description	Author Affiliation: Macha S ( Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut.); Mattheus M ( Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.); Pinnetti S ( Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.); Broedl UC ( Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany. Electronic address: uli.broedl@boehringer-ingelheim.com.); Woerle HJ ( Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.)
Abstract	PURPOSE: The aim was to investigate the effects of coadministration of the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin with the thiazolidinedione pioglitazone. METHODS: In study 1, 20 healthy volunteers received 50 mg of empagliflozin alone for 5 days, followed by 50 mg of empagliflozin coadministered with 45 mg of pioglitazone for 7 days and 45 mg of pioglitazone alone for 7 days in 1 of 2 treatment sequences. In study 2, 20 volunteers received 45 mg of pioglitazone alone for 7 days and 10, 25, and 50 mg of empagliflozin for 9 days coadministered with 45 mg of pioglitazone for the first 7 days in 1 of 4 treatment sequences. FINDINGS: Pioglitazone exposure (Cmax and AUC) increased when coadministered with empagliflozin versus monotherapy in study 1. The geometric mean ratio (GMR) for pioglitazone Cmax at steady state (Cmax,ss) and for AUC during the dosing interval at steady state (AUCτ,ss) when coadministered with empagliflozin versus administration alone was 187.89% (95% CI, 166.35%-212.23%) and 157.97% (95% CI, 148.02%-168.58%), respectively. Because an increase in pioglitazone exposure was not expected, based on in vitro data, a second study was conducted with the empagliflozin doses tested in Phase III trials. In study 2, pioglitazone exposure decreased marginally when coadministered with empagliflozin. The GMR for pioglitazone Cmax,ss when coadministered with empagliflozin versus administration alone was 87.74% (95% CI, 73.88%-104.21%) with empagliflozin 10 mg, 90.23% (95% CI, 66.84%-121.82%) with empagliflozin 25 mg, and 89.85% (95% CI, 71.03%-113.66%) with empagliflozin 50 mg. The GMR for pioglitazone AUCτ,ss when coadministered with empagliflozin versus administration alone was 90.01% (95% CI, 77.91%-103.99%) with empagliflozin 10 mg, 88.98% (95% CI, 72.69%-108.92%) with empagliflozin 25 mg, and 91.10% (95% CI, 77.40%-107.22%) with empagliflozin 50 mg. The effects of empagliflozin on pioglitazone exposure are not considered to be clinically relevant. Empagliflozin exposure was unaffected by coadministration with pioglitazone. Empagliflozin and pioglitazone were well tolerated when administered alone or in combination. In study 1, adverse events were reported in 1 of 19 participants on empagliflozin 50 mg alone, 4 of 20 on pioglitazone alone, and 5 of 18 on combination treatment. In study 2, adverse events were reported in 8 of 20 participants on pioglitazone alone, 10 of 18 when coadministered with empagliflozin 10 mg, 5 of 17 when coadministered with empagliflozin 25 mg, and 6 of 16 when coadministered with empagliflozin 50 mg. IMPLICATIONS: These results indicate that pioglitazone and empagliflozin can be coadministered without dose adjustments. EudraCT identifiers: 2008-006087-11 (study 1) and 2009-018089-36 (study 2).
File Format	HTM / HTML
ISSN	01492918
Issue Number	7
Volume Number	37
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2015-07-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Benzhydryl Compounds Blood Glucosides Hypoglycemic Agents Thiazolidinediones Adolescent Adult Area Under Curve Administration & Dosage Adverse Effects Cross-over Studies Dose-response Relationship, Drug Drug Administration Schedule Drug Interactions Drug Therapy, Combination Healthy Volunteers Humans Male Middle Aged Sodium-glucose Transporter 2 Antagonists & Inhibitors Young Adult Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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