NDLI: 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.

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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.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Chang, Ming Liu, Xiaoni Cui, Dapeng Liang, Dan LaCreta, Frank Griffen, Steven C. Lubin, Susan Quamina-Edghill, Donette Boulton, David W.
Description	Author Affiliation: Chang M ( Bristol-Myers Squibb, Princeton, New Jersey.); Liu X ( Bristol-Myers Squibb, Princeton, New Jersey.); Cui D ( ICON Development Solutions, San Antonio, Texas.); Liang D ( ICON Development Solutions, San Antonio, Texas.); LaCreta F ( Bristol-Myers Squibb, Princeton, New Jersey.); Griffen SC ( Bristol-Myers Squibb, Princeton, New Jersey.); Lubin S ( Bristol-Myers Squibb, Princeton, New Jersey.); Quamina-Edghill D ( Bristol-Myers Squibb, Princeton, New Jersey.); Boulton DW ( Bristol-Myers Squibb, Princeton, New Jersey. Electronic address: david.boulton@bms.com.)
Abstract	PURPOSE: Simplification of therapeutic regimens for patients with type 2 diabetes mellitus can provide convenience that leads to improved compliance. Dapagliflozin/metformin extended-release (XR) fixed-dose combination (FDC) tablets offer the convenience of once-daily dosing. Two pharmacokinetic (PK) studies were conducted to establish bioequivalence for 2 doses of dapagliflozin/metformin XR FDC versus the same dosage of the individual component (IC) tablets in healthy adults. METHODS: Two open-label, randomized, 4-period, 4-arm crossover studies were conducted to assess the bioequivalence and PK properties of dapagliflozin and metformin FDCs in healthy subjects under fed and fasting conditions. Participants received single oral doses or once-daily dosing of dapagliflozin/metformin XR (5 mg/500 mg [study 1] or 10 mg/1000 mg [study 2]) for 4 days in an FDC formulation or corresponding strengths of IC tablets. FINDINGS: For both of the studies, dapagliflozin and metformin 5 mg/500 mg or 10 mg/1000 mg FDC tablets were bioequivalent to the respective IC tablets. The 90% CIs of the ratio of the adjusted geometric means for all key PK parameters (Cmax, AUC0-T, and AUC0-∞) were contained within the predefined 0.80 to 1.25 range to conclude bioequivalence for both dapagliflozin and metformin. Once-daily dosing to steady state of each FDC tablet had no effect on the PK properties of dapagliflozin or metformin. When the FDCs were administered with a light-fat meal, there was no effect on metformin PK values and only a modest, nonclinically meaningful effect on dapagliflozin PK values. There were no safety or tolerability concerns. IMPLICATIONS: Bioequivalence of the FDCs of dapagliflozin/metformin XR and the ICs was established, and no safety issues of clinical concern were raised.
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 Food-drug Interactions Physiology Glucosides Hypoglycemic Agents Metformin Adult Administration & Dosage Adverse Effects Therapeutic Use Chemistry, Pharmaceutical Cross-over Studies Delayed-action Preparations Drug Administration Schedule Drug Combinations Fasting Female Healthy Volunteers Humans Male Middle Aged Tablets Therapeutic Equivalency Young Adult Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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