Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers

Healthy Clinical Trial

Official title:

An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on Fixed Dose Combination Dapagliflozin/Metformin Tablet (5 mg/1000 mg) in Healthy Male and Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156246
• Other study ID #: D1691C00005
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2010
• Last updated: May 31, 2012
• Start date: June 2010
• Est. completion date: August 2010

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy

• BMI 18-30 kg/m2

Exclusion Criteria:

• History of clinically significant illness.

• History of alcohol or drug abuse

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Dapagliflozin/Metformin
oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3.

Locations

Country	Name	City	State
Sweden	Research Site	Lulea

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin.	primary - single dose Cmax, AUCinf, AUC(0-t) of dapagliflozin and metformin.. secondary - single dose tmax, t1/2 of dapagliflozin and metformin	Serial PK sampling will be done on Days 1-4 at visit 2 and 3.	No
Secondary	To examine the safety and tolerability of the fixed-dose combination tablet of dapagliflozin and metformin.	Vital signs (blood pressure and heart rate), electrocardiogram, laboratory safety data (clinical chemistry, haematology and urinalysis), adverse events.	ECG at screening and follow-up. BP/pulse at screening, once daily during residential period and at follow-up. Clinical chemistry, haematology, and urine analyses at screening, day-1, day 4, and at follow-up.	Yes