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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin; Metformin

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