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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01055691

Collaborator

Bristol-Myers Squibb (Industry)

120

Enrollment

Location

Arms

Duration (Months)

40.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Dapagliflozin/Metformin Drug: Dapagliflozin Drug: Metformin Drug: Dapagliflozin/Metformin Drug: Dapagliflozin Drug: Metformin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: Glucophage

Outcome Measures

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. [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.]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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