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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055691
• Other study ID #: D1691C00002
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2010
• Last updated: May 31, 2012
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Dapagliflozin/Metformin
Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose
• Dapagliflozin
dapagliflozin tablet 2.5 mg Oral Single dose
• Metformin
metformin IR tablet 850 mg Oral Single dose
• Dapagliflozin/Metformin
Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose
• Dapagliflozin
dapagliflozin tablet 5 mg Oral Single dose
• Metformin
metformin IR tablet 1000 mg Oral Single dose

Locations

Country	Name	City	State
Germany	Research Site	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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)	Yes