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A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Dapagliflozin/Metformin (Drug); Dapagliflozin (Drug); Metformin (Drug); Dapagliflozin/Metformin (Drug); Dapagliflozin (Drug); Metformin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Georg Golor, M.D., Principal Investigator, Affiliation: PAREXEL International GmbH
Thomas Koernicke, Study Director, Affiliation: PAREXEL International GmbH

Summary

The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet.

Clinical Details

Official title: A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Volunteers, in the Fed State

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.

Secondary outcome: To examine the safety and tolerability of the combination of dapagliflozin and metformin.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Female healthy volunteers must be post-menopausal (cessation of menses >1year), be

surgically sterile (documented) or hysterectomy or on abstinence

- Have normal physical exam, vital signs Electrocardiogram (ECG) findings, and

laboratory values Exclusion Criteria:

- Use of prescription medication for a chronic or acute medical condition within 3

weeks of randomization

- History of allergy to metformin

- Previous participation in an AstraZeneca (AZ) or BristolMyers-Sqibb dapagliflozin

study

Locations and Contacts

Research Site, Berlin, Germany
Additional Information

Starting date: January 2010
Last updated: May 31, 2012

Page last updated: August 23, 2015

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