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

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ClinicalTrials.gov Identifier: NCT01002807
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus (T2DM) Drug: Dapagliflozin Drug: Metformin XR Drug: Glucophage Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : November 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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™




Primary Outcome Measures :
  1. 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 ]

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


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002807


Locations
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United States, Texas
Ppd Development, Lp
Austin, Texas, United States, 78744
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01002807    
Other Study ID Numbers: MB102-065
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Dapagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action