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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01055691
First received: January 25, 2010
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Dapagliflozin/Metformin
Drug: Dapagliflozin
Drug: Metformin
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the safety and tolerability of the combination of dapagliflozin and metformin. [ Time Frame: Throughout study (for 4 days in each period and a follow-up visit ~6 days later) ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
Drug: Dapagliflozin/Metformin
Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose
Drug: Dapagliflozin
dapagliflozin tablet 2.5 mg Oral Single dose
Drug: Metformin
metformin IR tablet 850 mg Oral Single dose
Other Name: Glucophage
Experimental: 2
Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
Drug: Dapagliflozin/Metformin
Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose
Drug: Dapagliflozin
dapagliflozin tablet 2.5 mg Oral Single dose
Drug: Metformin
metformin IR tablet 850 mg Oral Single dose
Other Name: Glucophage
Experimental: 3
Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
Drug: Dapagliflozin/Metformin
Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose
Drug: Dapagliflozin
dapagliflozin tablet 5 mg Oral Single dose
Drug: Metformin
metformin IR tablet 1000 mg Oral Single dose
Other Name: Glucophage
Experimental: 4
Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
Drug: Dapagliflozin/Metformin
Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose
Drug: Dapagliflozin
dapagliflozin tablet 5 mg Oral Single dose
Drug: Metformin
metformin IR tablet 1000 mg Oral Single dose
Other Name: Glucophage

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055691

Locations
Germany
Research Site
Berlin, Germany
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Principal Investigator: Georg Golor, M.D. PAREXEL International GmbH
Study Director: Thomas Koernicke PAREXEL International GmbH
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01055691     History of Changes
Other Study ID Numbers: D1691C00002
Study First Received: January 25, 2010
Last Updated: May 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

Keywords provided by AstraZeneca:
healthy volunteers
bioequivalence
dapagliflozin
metformin

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014