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

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: Dapagliflozin/Metformin Drug: Dapagliflozin Drug: Metformin	Phase 1

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

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. [ Time Frame: Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the safety and tolerability of the combination of dapagliflozin and metformin. [ Time Frame: Throughout study (for 4 days in each period and a follow-up visit ~6 days later) ] [ Designated as safety issue: Yes ]

Enrollment:	120
Study Start Date:	January 2010
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet	Drug: Dapagliflozin/Metformin Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose Drug: Dapagliflozin dapagliflozin tablet 2.5 mg Oral Single dose Drug: Metformin metformin IR tablet 850 mg Oral Single dose Other Name: Glucophage
Experimental: 2 Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets	Drug: Dapagliflozin/Metformin Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose Drug: Dapagliflozin dapagliflozin tablet 2.5 mg Oral Single dose Drug: Metformin metformin IR tablet 850 mg Oral Single dose Other Name: Glucophage
Experimental: 3 Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet	Drug: Dapagliflozin/Metformin Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose Drug: Dapagliflozin dapagliflozin tablet 5 mg Oral Single dose Drug: Metformin metformin IR tablet 1000 mg Oral Single dose Other Name: Glucophage
Experimental: 4 Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets	Drug: Dapagliflozin/Metformin Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose Drug: Dapagliflozin dapagliflozin tablet 5 mg Oral Single dose Drug: Metformin metformin IR tablet 1000 mg Oral Single dose Other Name: Glucophage

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055691

Locations

Germany
Research Site
Berlin, Germany

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Principal Investigator:	Georg Golor, M.D.	PAREXEL International GmbH
Study Director:	Thomas Koernicke	PAREXEL International GmbH

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01055691 History of Changes
Other Study ID Numbers:	D1691C00002
Study First Received:	January 25, 2010
Last Updated:	May 31, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Germany: Ethics Commission

Keywords provided by AstraZeneca:

healthy volunteers
bioequivalence
dapagliflozin
metformin

Additional relevant MeSH terms:

Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013