Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01002807
First received: October 26, 2009
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.


Condition Intervention Phase
Type 2 Diabetes Mellitus (T2DM)
Drug: Dapagliflozin
Drug: Metformin XR
Drug: Glucophage
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Bioavailability Study of Two Prototype Fixed Dose Combination (FDC) Formulations of 10 mg Dapagliflozin and 1000 mg Metformin Extended Release (XR) Tablet Relative to Dapagliflozin 10 mg Tablet and Glucophage® XR 2 X 500 mg Tablets Coadministered to Healthy Subjects in a Fasted State

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone [ Time Frame: 48 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments) [ Time Frame: 15 timepoints in 48 hours time interval ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: November 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
FDC of dapagliflozin/metformin XR Drug: Dapagliflozin
Tablets, Oral, 10 mg, Single Dose
Drug: Metformin XR
Tablets, Oral, 1000 mg, Single Dose
FDC of dapagliflozin/reduced mass metformin XR Drug: Dapagliflozin
Tablets, Oral, 10 mg, Single Dose
Drug: Metformin XR
Tablets, Oral, 1000 mg, Single Dose
dapagliflozin and Glucophage® XR Drug: Dapagliflozin
Tablets, Oral, 10 mg, Single Dose
Drug: Glucophage
Tablets, Oral, 1000 mg, 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:

  • Men and women ages 18 to 45 inclusive
  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months) gastrointestinal disease
  • Any major surgery within 4 weeks of study drug administration
  • Glucosuria at screening
  • Abnormal liver functions tests (ALT, AST or total bilirubin > 10% above ULN)
  • Presence of edema on physical exam
  • History of diabetes mellitus
  • History of heart failure
  • History of renal insufficiency
  • History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
  • History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
  • Estimated creatinine clearance (ClCR) of < 80 mL/min using the Cockcroft Gault formula
  • History of allergy or intolerance to metformin or other similar agents
  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: NCT01002807

Locations
United States, Texas
Ppd Development, Lp
Austin, Texas, United States, 78744
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01002807     History of Changes
Other Study ID Numbers: MB102-065
Study First Received: October 26, 2009
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014