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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Dapagliflozin/Metformin; Drug: Dapagliflozin; Drug: Metformin

• Registration Number: NCT01055691
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Dapagliflozin/Metformin	Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
2	Dapagliflozin/Metformin	Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
2	Metformin	Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
3	Dapagliflozin/Metformin	Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
3	Dapagliflozin	Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
4	Dapagliflozin/Metformin	Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
4	Dapagliflozin	Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
4	Metformin	Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
3	Metformin	Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
1	Dapagliflozin	Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
1	Metformin	Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
2	Dapagliflozin	Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Research Site; 🇩🇪 Berlin, Germany