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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

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

Page last updated: August 23, 2015

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