A Study to to Assess the Effect of Dapagliflozin When Administered Once a Day Versus Twice a Day on Blood Glucose

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

Summary

The primary objective of the study is to assess the effect of dapagliflozin on the amount of glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus twice a day (5 mg every 12 hours) after five days of dosing.

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

Details

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

Criteria

Inclusion Criteria:

• Female healthy volunteers must be post-menopausal (cessation of menses >1year, be surgically sterile (documented) or have undergone hysterectomy) or be sexually abstinent from enrolment until follow-up examination

• Have normal physical exam, vital signs ECG findings, and laboratory values

Exclusion Criteria:

• Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization

• History or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs as determined by the Investigator

• Previous participation in an AstraZeneca (AZ) or Bristol-Myers Squibb (BMS) dapagliflozin study