Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus (T2DM)
Intervention: Dapagliflozin (Drug); Metformin XR (Drug); Glucophage (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
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 GlucophageŽ XR tablets, in
healthy subjects in a fasted state.
Clinical Details
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 GlucophageŽ XR 2 X 500 mg Tablets Coadministered to Healthy Subjects in a Fasted State
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone
Secondary outcome: Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments)
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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
Locations and Contacts
Ppd Development, Lp, Austin, Texas 78744, United States
Additional Information
BMS Clinical Trials Disclosure Investigator Inquiry form For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: November 2009
Last updated: March 20, 2015
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